Craniomaxillofacial (CMF) Distraction System. A modular ...synthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes... · Distraction System is intended for use as a bone stabilizer and

Craniomaxillofacial (CMF) DistractionSystem. A modular family of internaldistraction devices to lengthen themandibular body and ramus.

Technique Guide

Introduction

Surgical Technique

Product Information

Table of Contents

Craniomaxillofacial (CMF) Distraction System 2

Indications and Contraindications 5

Preoperative Planning 6

Distractor Assembly 7

Mandible Body Lengthening 19

Postoperative Considerations 28

Extension Arm Removal 31

Device Removal 32

Implants 33

Instruments 37

Set List 44

References 49

Craniomaxillofacial (CMF) Distraction System Technique Guide Synthes

2 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide

Craniomaxillofacial (CMF) Distraction System

A modular system of intraoral distractiondevices offered in a variety of designsand sizes to fit patient anatomy. + + =

Footplates– Available in cloverleaf and mesh

designs

– Available in four sizes for use in a wide range of patients: 1.0 mm and 1.3 mm for children under 12 months of age, and 1.5 mm and 2.0 mm for older patients

Cloverleaf footplates

1.0 mm 1.3 mm

1.5 mm 2.0 mm

1.0 mm 1.3 mm

1.5 mm 2.0 mm

Mesh footplates

Craniomaxillofacial (CMF) Distraction System Technique Guide Synthes 3

– 1.5 mm and 2.0 mm mesh footplatesavailable in elevated design to facilitate parallel placement of thedistractors

– Elevated mesh available in 5.5 mmoffset and 7.5 mm offset

Elevated mesh footplates

1.5 mm

2.0 mm

2.0 mm titanium locking screws– 2.0 mm footplates accept Synthes2.0 mm locking screws

– Provide greater stability

5.5 mmoffset

7.5 mmoffset

Craniomaxillofacial (CMF) Distraction System


Rigid extension arm

Flexibleextension arm

End-translating (BC distractor shown with universal joint)

Center-translating (AB distractor shown without universal joint)

Distractor bodies– Offered in center-translating (AB distractor) and end-

translating (BC distractor) designs, for maximum placement options of the distractor on the mandible

– Available with or without a universal joint. Universal joints allow ± 35º of angulation of extension arms

AB distractor bodies – Footplates can be placed more anteriorly on the mandible

with half of the distractor initially positioned posterior to the osteotomy

BC distractor bodies– Footplates can be placed more posteriorly on the mandible

with the distractor body initially positioned either anterioror posterior to the osteotomy, depending on the orientation

Extension arms – Allow the point of activation to be moved away

from the distractor body for easier access with the activation instrument

– May be placed intraorally or percutaneously

– May be removed for patient comfort, during the consolidation phase, without a surgical procedure


IndicationsThe Synthes Craniomaxillofacial (CMF)Distraction System is intended for useas a bone stabilizer and lengthening(and/or transport) device for correctionof congenital deficiencies or posttrau-matic defects of the mandibular bodyand ramus, where gradual bone distraction is required. The SynthesCMF Distraction System is intended for single use only.

The Synthes Pediatric CMF DistractionSystem is intended for use as a bonestabilizer and lengthening (and/ortransport) device for correction of congenital deficiencies or posttraumaticdefects of the mandibular body and ramus where gradual bone distractionis required in children under the age of12 months. The Synthes Pediatric CMFDistraction System is intended for single use only.

ContraindicationsUse of the Synthes CMF DistractionSystem is contraindicated in patientspreviously sensitized to nickel.

Indications and Contraindications


Preoperative Planning

Preoperative planning Determine the postdistraction anatomic goal by conductingan evaluation of the craniofacial pathology and asymmetrythrough clinical exam, CT scan, cephalogram and/or panoramicx-ray. Anatomical models are beneficial in cases of severemandibular hypoplasia for selecting appropriate distractorcomponents, determining the location of the osteotomy andplacement of the devices, and for pre-bending the footplates.


Distractor Assembly

A-stylefootplate

B-stylefootplate

C-stylefootplate

2Select footplates

Select two footplates (either A-style and B-style or B-style andC-style) according to the treatment plan and selected distractorbody, giving special consideration to the patient’s anatomy.

Note: Footplates must mate with the selected distractorbody. If an AB distractor body is selected, one A-style andone B-style footplate must be used. If a BC distractor body isselected, one B-style and one C-style footplate must be used.

1Select distractor body

Select the appropriate design and length distractor body according to the treatment plan.

Note: To ensure that the soft tissue does not obstruct the activation hex during distraction, the next longer size distractor body and/or extension arm may need to be used.

End-translating (BC distractor body shown with universal joint and 1.5 mm mesh footplates)

Center-translating (AB distractor body shown with 1.5 mm mesh footplates)


Distractor Assembly

There are different steps for attaching the footplates to theAB and BC distractor bodies.

3aAssemble footplates–AB distractor

Instruments

311.005 Screwdriver Handle with Hex Coupling, small

311.006 Screwdriver Handle with Hex Coupling,medium

313.252 1.5 mm/2.0 mm Screwdriver Blade, self-retaining, PlusDrive, 96 mm


Use the 1.5 mm/2.0 mm screwdriver blade to remove the machine screw and collar from the distractor body.

Set these aside for later reassembly.

Remove the lead screw by sliding it out of the distractor body.

Collar


Thread the B-style footplate onto the hex end of the leadscrew and rotate the footplate counterclockwise until itreaches the center of the lead screw. An etched “B” alongwith an arrow on the center of the lead screw indicatesproper placement of the B-style footplate.

Thread the A-style footplate onto the opposite end of the lead screw and rotate the footplate clockwise until it reaches the center of the lead screw. An “A” and an arroware etched on the center of the lead screw to assist in assembling the footplate.

Hex end

Non-hex end


Distractor Assembly

3aAssemble footplates–AB distractor continued

Notes: Footplates should be aligned parallel to each other atthe center of the lead screw.

Footplates should be positioned so that the screw holespoint away from one another, as shown.

Insert the hex end of the lead screw (the end with the B-stylefootplate) back into the distractor body.

Correct

Incorrect

Hex end


Slide the lead screw all the way into the distractor until it seats in the activation hex.

Retrieve the previously disassembled machine screw and collar.

Place the collar onto the distractor body. Etched lines on thecollar and distractor body aid in realignment.

Use the 1.5 mm/2.0 mm screwdriver blade to reinsert the machine screw into the collar and distractor body and fullytighten, locking the construct together.

Correct Incorrect


Distractor Assembly

3aAssemble footplates–AB distractor continued

Notes: Once the distractor is fully assembled, rotate the activation hex counterclockwise to verify that the footplatesare translating and the distractor is functioning properly. The distractor will not activate if the collar is not reattached or if the distractor is assembled improperly.

Return the footplates to the original position by turning theactivation hex clockwise until the footplates reach the centerof the distractor body.

When the distractor is fully assembled, the slot on the distractor body will face medially and the screw hole countersinks will face laterally.

Final AB distractor assembly with footplates in the home position

Underside of the final AB distractor assembly

Screw hole countersinks

Slot on the distractor body


3bAssemble footplates–BC distractor

Instruments





Use the 1.5 mm/2.0 mm screwdriver blade to remove the machine screw from the distractor body.

Insert the B-style footplate into the open end of the distractor body in the correct orientation, as shown.

Note: The screw holes on the B-style footplate should be positioned so that they point toward the activation hex and not the open end of the distractor. Correct

Incorrect


Distractor Assembly

3bAssemble footplates–BC distractor continued

Turn the activation hex counterclockwise to engage the B-style footplate with the lead screw. Rotate the activationhex at least 6 full turns to allow room for the C-style footplate.

Technique tip: The activation instrument can be used toturn the activation hex.

Attach the C-style footplate by fitting it over the open end of the distractor body.

Use the 1.5 mm/2.0 mm screwdriver blade to reinsert themachine screw into the distractor body and fully tighten,locking the construct together.


Notes: Once the distractor is fully assembled, ensure thatthe B-style footplate is in the “home” position by turning the activation hex clockwise until the two footplates meet.

When the distractor is fully assembled, the slot on the distractor body will face medially and the screw hole countersinks will face laterally.

Final BC distractor assembly with footplates in the home position

Underside of the final BC distractor assembly

Screw hole countersinks

Slot on the distractor body


Distractor Assembly

4Attach extension arm (optional)

Instrument

03.315.004 Removal Instrument, for CMF Distractor

Determine if an extension arm will be needed to place the activation hex in an area easily accessible with the activation instrument.

Note: To ensure that the soft tissue does not obstruct the activation hex during distraction, the next longer size extension arm may need to be used.

There are two versions of flexible extension arms and they attach to the distractor differently. If the extension arm isetched with the Synthes logo on the outer sleeve, it attaches tothe distractor with spring fingers (Figures 1-2). If the extension arm is etched with a line on the activation hex, it attaches tothe distractor with a hex pocket (Figures 3-4). The instructionsfor use below provide details for both versions of extension arm.

Engage the removal instrument with the hex on the extension arm (Figure 5).

Rotate the removal instrument collar counterclockwise atleast 16 full turns until the spring fingers (figure 2) or the hexpocket (figure 4) of the extension arm is exposed.

Technique tips: Extension arms are provided fully tightenedto prevent unintentional separation. When opening an extension arm for the first time, there will be significant resistance. Rotate counterclockwise in the direction marked“OPEN,” past the point of resistance.

Lay the extension arm in the palm of your hand when rotating the removal instrument collar to expose the springfingers or the hex pocket (Figure 6). Alternatively, the extension arm can be held in the removal instrument withoutany support (Figure 7). Gripping the extension arm with yourfingers will make it difficult to open and cause the siliconesleeve to twist and possibly tear.

Figure 1

Figure 3

Figure 2

SpringFingers

Figure 4

Hex pocket

Figure 5

Figure 6 Figure 7

Etched line

Technique tips continued: The extension arm is composed oftwo sleeves. If the extension arm separates (the outer sleeve,separates from the inner sleeve) it is possible to reassemble it.Reassemble the extension arm by inserting the inner sleeveinto the outer sleeve and rotating the outer sleeve clockwiseuntil it fully closes (Figure 8).

Extension arms can be detached from the distractor at thestart of the consolidation phase without the need for a surgical procedure (see page 31 for instructions).

For the spring finger extension arm, slide the extension armover the distractor body activation hex so that the spring fingers engage the activation hex. If the spring fingers donot slide over the activation hex, slightly rotate the extensionarm clockwise while pushing toward the distractor to fullyengage (figure 9).

For the hex pocket extension arm, place the distractor bodyactivation hex into the hex pocket of the extension arm (figure 10).

Rotate the removal instrument collar clockwise until the extension arm closes over the activation hex of the distractor,and fully tighten. Visually verify that the flange of the extension arm covers the collar of the distractor (figure 11).


Figure 10

Figure 8

Figure 9

Activation hex

Figure 11

Activation hex

Collar

Hex pocket

Flange

Distractor Assembly


Warning: During the course of treatment, care should betaken to protect the extension arms and prevent damage orbreakage. Lateral forces from a patient rolling on the flexibleextension arms during sleep can damage and/or break theextension arms. It is advised to secure the flexible extensionarms to the patient’s skin, without affecting the arm’s abilityto rotate. As an alternative, rigid extension arms are available.

5Assemble second distractor

For bilateral procedures, repeat Steps 1 through 4 to assemble a distractor for the contralateral side.

Distractor assembly with removable extension arm attached


Mandible Body Lengthening

The following surgical technique is an example of an intraoralapproach with the distractor placed in an anterior orientationwith intraoral activation. A similar technique can be used for placing the distractor in a posterior orientation with a percutaneous activation port. The distractor can also beplaced on the mandibular ramus.

1Make incision

Make a mandibular vestibular or a submandibular incision.Elevate the periosteum to expose the mandible.



2Mark osteotomy

Mark the approximate site of the osteotomy.

3Fit distractor

Place a fully assembled distractor in the intended area to assess the patient’s anatomy and determine the approximatelocation of the footplates and extension arm.

Factors to consider include:

– Occlusal plane

– Tooth buds and roots

– Planned vector of distraction

– Adequate bone for screw placement

– Location of mental nerve and inferior dental nerve

– Lip closure

– Soft tissue (mucosa) coverage

– Location of activation hex


Ideal Acceptable Not preferable

3Fit distractor continued

Optional technique

Instrument

03.315.003 Alignment Rod, for CMF Distractor

Alignment rods can be used throughout the course of surgery to:– Aid in parallel placement of the devices

– Indicate the vectors of advancement

– Hold the distractors during screw fixation and device placement

To use the alignment rods, place the open end of the alignment rod over the distractor body or extension arm.

Slide the alignment rod sleeve forward until it meets thethreaded portion of the rod and rotate clockwise until therod tightens onto the distractor.

Important: The alignment rods should not be used as leverage for bending the footplates as this may cause damage to the distractor bodies.

While parallel placement of the distractors is ideal, this may be difficult to accomplish considering the patient’s soft tissue coverage, and could potentially lead to patientdiscomfort. A slight convergence of the distraction vector is acceptable to ensure patient comfort.

The point of convergence should be farther from the patientfor larger advancements and can be closer to the patient forsmaller advancements.



4Cut and contour footplates

Instruments

03.500.014 Cutting Instrument

03.503.039 Plate Cutter

347.964 Combination Bending Pliers, for 1.0 mm and 2.0 mm plates

391.965 Combination Bending/Cutting Pliers, for 1.0 mm and 2.0 mm plates

Cut the footplates to remove any unnecessary screw holes.

Technique tips: Activate the distractor to separate the footplates to aid in cutting.

Cut the footplates so the cut edges are flush with the distractor body.

Screws can be placed in the holes superior to the distractorbody in the posterior footplate and in the holes inferior tothe distractor body in the anterior footplate for added stability.

A minimum of three screws should be used in each footplateto ensure adequate stability.

Take care to avoid placing screws in tooth buds or roots.

Contour the footplates to the mandible using the combination bending pliers.

Caution: Repeat bending may damage the footplates.


5Mark distractor location

Instruments



Use the appropriate drill bit and screwdriver blade for thefootplate size selected.

Footplate Drill bit Screwdriversize size blade

1.0 mm 0.76 mm 1.0 mm

1.3 mm 1.0 mm 1.3 mm

1.5 mm 1.1 mm 1.5 mm or 1.5 mm/2.0 mm

2.0 mm 1.5 mm 1.5 mm/2.0 mm or 2.0 mm

Mark the position of the distractor before making the osteotomy by drilling and/or inserting one appropriatelength screw through each footplate.

Do not fully tighten the screws.

Caution: Drill rate should never exceed 1800 RPM. Higherrates can result in thermal generated necrosis of the bone,and an oversized hole to be drilled. The detriments of anoversized hole include reduced pullout force, increased easeof screws stripping in bone, and/or suboptimal fixation. Always irrigate during drilling.



Optional InstrumentsUniversal Trocar System for 1.5 mm and 2.0 mm screws/ footplates

397.211 Universal Trocar Handle

397.213 2.0 mm Cannula and Obturator

397.232 Malleable C-Retractor

397.42 2.0 mm Cheek Retractor Blade

397.43 2.0 mm Cheek Retractor Ring

Pediatric Trocar System for 1.0 mm and 1.3 mmscrews/ footplates

03.315.007 Pediatric Drill Guide

03.315.008 Obturator for Pediatric Drill Guide

03.315.009 Cheek Retractor for Pediatric Drill Guide

Optional technique–using the pediatric trocarMake a stab incision through the buccal soft tissue by slidingthe obturator through the drill guide cannula and piercingthe soft tissue. Remove the obturator from the drill guide.

Grasp the cheek retractor with forceps. There are holes inthe outer surface of the cheek retractor that are designed to facilitate a secure hold with forceps.

Insert the drill guide through the buccal soft tissue and introduce the cheek retractor into the intraoral cavity. Placethe drill guide through the hole in the center of the cheek retractor.

Rotate the knurled collar on the drill guide to move thecheek retractor ring up the drill guide. Disengage the forcepsfrom the cheek retractor. Retract the soft tissue as needed.

Technique tips: For the pediatric trocar, maintain pressureon the drill guide during drilling and screw insertion to ensure the drill guide remains aligned over the screw holes in the footplate.

It may be helpful to have a Synthes 90° Screwdriver Set(01.505.002) available for intraoral approaches.

Use 75 mm length 0.76 mm and 1.0 mm drill bits with thepediatric trocar.


6Perform buccal corticotomy

Unscrew and remove the distractor.

Perform the corticotomy on the buccal side of the mandibleextending into the superior and inferior borders. This allows stability of the bone segment during reattachmentof the distractor.

7Reattach distractor

Instruments



Use the appropriate drill bit and screwdriver blade for thefootplate size selected (see page 22).

Reattach the distractor by aligning the footplates with theholes made previously. Drill and/or insert remaining screws.Fully tighten all screws.

Notes: A minimum of three screws should be inserted througheach footplate to ensure adequate stability. It is recommendedto use screw holes closest to the distractor body.

Depending on patient anatomy and placement of the distractor,the extension arm can either remain in the intraoral cavity orproject through a small percutaneous activation port. If theextension arm remains in the intraoral cavity, care should betaken to ensure that it does not interfere with the patient’sability to eat.



Extension arms can be secured below the dentition with a loop of wire attached to orthodontic brackets or to the teeth. The loop should restrict the vertical movement of the ex-tension arm without affecting the arms’ ability to rotate. Thiswill ensure that the extension arm does not interfere with mastication.

Cautions: Screws can loosen during the course of treatment ifplaced in poor quality bone.

Drill rate should never exceed 1800 RPM. Higher rates can resultin thermal generated necrosis of the bone, and an oversizedhole to be drilled. The detriments of an oversized hole includereduced pullout force, increased ease of screws stripping inbone, and/or suboptimal fixation. Always irrigate during drilling.

If locking screws are used, screw holes must be drilled at a right angle to the plate hole to prevent the screws from becoming cross threaded. A drill guide is provided to facilitate proper placement.


8Complete osteotomy

Complete the osteotomy on the lingual aspect of themandible using an osteotome. Take care to avoid transectionof the inferior alveolar nerve.

Important: The osteotomy must be complete and the bonemust be mobile. The distractor is not designed or intendedto break bone and/or complete the osteotomy.

9Confirm device activation

Instruments

03.315.001 Activation Instrument, 1.7 mm

03.315.005 Activation Instrument, 1.7 mm with U-Joint

Use an activation instrument to engage the activation hex of the distractor or extension arm. Rotate in a counterclock-wise direction, as marked on the handle, to confirm devicestability and verify movement of the mandible. Return thedistractor to its original position.

10Repeat steps for bilateral procedures

Repeat Steps 1 through 9 on the contralateral side. Close all incisions.


Activation instrument

Activation instrument (with blue machine screw removed)

Suggested distraction protocol

Instruments



It is recommended to begin distraction three to five days afterdevice placement. For young patients, distraction can beginearlier to prevent premature consolidation.

To activate the distractors, engage an activation instrumentwith the activation hex and rotate counterclockwise (in thedirection of the arrow marked on the instrument).

The instrument can be made smaller for use in young patients, by removing the blue machine screw.

Postoperative Considerations

Rate of activation The AB and BC distractors advance at different rates.

AB distractor BC distractor

1 full turn with activation instrument 0.70 mm of linear advancement 0.35 mm of linear advancement

Recommended number of turns per day based on patient age:1, 2, 3

< 1 year old (1.8 mm/day) 2 1⁄2 turns (1.75 mm) 5 turns (1.75 mm)

> 1 year old (1 mm/day) 1 1⁄2 turns (1.05 mm) 3 turns (1.05 mm)


Notes: To accomplish a half-turn, rotate the activation instrument from the side with the arrow marked on it to the side with the open slot.

1.0 mm of linear advancement per day is the standard rateof activation and allows for optimal osteogenesis of the regenerate.4 Distraction of less than 1 mm per day can beconsidered for cases of compromised bone healing such as heavy smokers, previously radiated patients and patientson bisphosphonates. Distraction of more than 1 mm per dayis recommended to prevent premature consolidation inyoung children and neonates.


Document progressDistraction progress should be observed by documenting the changes in the patient’s occlusion. A Patient Care Guideis included with the system to help record and monitor device activation.

Patient careIf the distractors are placed so they are activated intraorally,silicone tip guards can be inserted over the activation end ofthe distractor to help prevent soft tissue irritation. The tipguards need to be removed to activate the distractor and canbe reinserted after activation.

If the distractors are placed with the extension arms in theintraoral cavity, care must be taken to prevent the arms frominterfering with mastication. Extension arms can be securedbelow the dentition with a loop of wire attached to orthodonticbrackets or to the teeth. The loop should restrict the verticalmovement of the extension arm without affecting the arm’sability to rotate. This will ensure that the extension arm doesnot interfere with mastication.

If the distractors are placed with the extension arms exitingthrough percutaneous ports, it is important that the extensionarms be protected from catching on objects that could pullthe devices and cause the patient pain or injury.

Warning: Care should be taken to protect the extension arms,during the course of treatment, to prevent them from beingdamaged or broken. Lateral forces from a patient rolling on theflexible extension arms during sleep can damage and/or breakthe extension arms. It is advised to secure the flexible extensionarms to the patient’s skin, without affecting the arms ability torotate. As an alternative, rigid extension arms are available.

ConsolidationAfter the desired advancement has been achieved, the newbone must be given time to consolidate. The consolidationperiod should be approximately six to twelve weeks.2 Thistime period may vary in relation to patient age and extent ofmandibular advancement. The timing of distractor removalshould be determined by clinical evaluation and radiographicor CT evidence of bone healing.

If extension arms were used, they can be removed at the startof the consolidation phase. Doing so allows the distractor bodyto be embedded in the soft tissue and minimizes the chanceof mucosal infection around the extension arms.

Postoperative Considerations


Extension Arm Removal

Collar

Base

Extension arm removal

Instrument

03.315.004 Removal Instrument, for CMF Distractor

There are two versions of flexible extension arms and theyare removed from the distractor differently. If the extensionarm is etched with the Synthes logo on the outer sleeve, it is connected to the distractor with spring fingers (finger 1). Ifthe extension arm is etched with a line on the activation hex,it is connected to the distractor with a hex pocket (figure 2).The instructions for use below provide details for both versions of extension arm.

Engage the removal instrument with the extension arm.

Rotate the removal instrument collar counterclockwise atleast 16 full turns. This will unscrew the outer sleeve of the extension arm and expose the area where the extension arm connects to the distractor.

For the spring finger extension arm, disengage the extensionarm from the distractor by pulling it axially and remove theextension arm through the percutaneous port, or intraoralcavity.

For the hex pocket extension arm, disengage the extensionarm from the distractor with side-to-side movements of thearm. Remove the extension arm through the percutaneousport or intraoral cavity.

Warning: When removing the extension arms, rotate onlythe collar of the removal instrument. Do not allow the baseof the removal instrument to rotate in your hand, as doingso may result in a change in the distraction distance that hasbeen achieved.

Notes: (for hex pocket extension arm only) The line etchedon the hex end of the extension arm corresponds to the direction of the hex pocket opening at the top of the extension arm. Pushing the extension arm in the direction of the line should disengage it from the distractor.

Etched line

Figure 1 Figure 2


Device Removal

Optional technique

Instruments



347.964 Combination Bending Pliers, for 1.0 mm and 2.0 mm plates

If the removal instrument is not available, the extension armscan be removed using an activation instrument and pliers.Engage the extension arm with the activation instrument.While holding the activation instrument still, use the pliersto rotate the sleeve on the extension arm counterclockwise at least 16 full turns to expose the hex pocket where the extension arm connects to the distractor. Disengage the extension arm from the distractor by pulling axially for thespring finger extension arm or with side-to-side movementsfor the hex pocket extension arm.

Device removal

Instruments



Use the appropriate screwdriver blade for the footplate size used (see page 22).

Remove the distractors by exposing the footplates, throughthe same incisions that were used during the initial placementsurgery, and removing the titanium bone screws.

Note: The distractors are easier to remove if the extensionarms are removed before distractor removal. This will alsohelp keep the intraoral cavity from contacting the externallyexposed extension arm.


1.5 mm

Implants

Footplates– Available in A, B, and C styles to

mate with the selected distractorbody. Each footplate is etched with a style letter designation

– Available in four sizes: 1.0 mm and 1.3 mm for children under 12 months of age; 1.5 mm and 2.0 mm for older patients

– Footplates are used with corresponding size titanium bone screws

– Available in cloverleaf and mesh designs

– Symmetrical for use on both sides of the mandible

– 1.5 mm and 2.0 mm mesh footplatesavailable in elevated designs to facilitate parallel placement of thedistractors

– Elevated designs available in 5.5 mmoffset and 7.5 mm offset

– Material: Commercially pure titanium

A-style B-style C-style

Cloverleaf footplates

1.0 mm

1.3 mm

1.5 mm 2.0 mm

1.3 mm

2.0 mm

Mesh footplates

1.0 mm


Implants

Elevated mesh footplates

1.5 mm

2.0 mm

2.0 mm titanium locking screw

5.5 mmoffset

7.5 mmoffset

– 2.0 mm footplates accept Synthes 2.0 mm titanium locking screws

– Material: Titanium alloy (Ti-6AI-7Nb)


Activationhex

C-stylefootplate

B-stylefootplate

Distractor body

Machinescrew

Collar

Machinescrew

BC distractor body with universal joint

BC distractor body

AB distractor body with universal joint

AB distractor body

A-stylefootplate

B-style footplate

Distractor body (lead screw inside)

Activationhex

BC distractor bodies– End-translating distractor bodies work with B-style

and C-style footplates

– Both footplates are positioned at one end of the distractor.When the distractor is activated, the B-style footplatetranslates down the distractor away from the C-style footplate, which remains stationary

– Footplates can be placed more posteriorly on the mandiblewith the distractor body initially positioned either anterioror posterior to the osteotomy, depending on the orientation

– Available in 15 mm, 20 mm, 25 mm, 30 mm, 35 mm and40 mm lengths

Distractor bodies– Offered in center-translating (AB distractor) and

end-translating (BC distractor) designs

– Available with or without a universal joint

– Materials: Titanium alloy (Ti-6AI-7Nb) and cobalt chromium alloy (Co-20Cr-15W-10Ni)

AB distractor bodies – Center-translating distractor bodies work with A-style

and B-style footplates

– Both footplates are positioned in the center of the distractor and move laterally away from one another when the distractor is activated

– Footplates can be placed more anteriorly on the mandiblewith half of the distractor initially positioned posterior tothe osteotomy

– Available in 15 mm, 20 mm, 25 mm and 30 mm lengths


Rigid extension arm

Flexibleextension arm

Extension arms– Allow the point of activation to be moved away from the

distractor for easier access with the activation instrument

– Can be placed intraorally or percutaneously

– May be removed during the consolidation phase without a surgical procedure (see page 30)

– Rigid arms available in 20 mm, 40 mm, and 60 mm lengths,flexible arms available in 30 mm, 40 mm and 60 mm lengths

– Materials: Titanium alloy, cobalt chromium alloy and silicone

Implants


Instruments

03.307.002 Silicone Tip Guard

03.315.001 Activation Instrument, 1.7 mm, for CMF Distractor

03.315.003 Alignment Rod, for CMF Distractor

03.315.004 Removal Instrument, for CMF Distractor(For attaching and removing extension arms)

03.315.005 Activation Instrument, 1.7 mm with U-Joint, for CMF Distractor


Instruments

03.315.009 Cheek Retractor for Pediatric Drill Guide

03.315.010 0.76 mm Drill Bit, Stryker J-latch, 14 mm stop, 75 mm length

03.315.011 1.0 mm Drill Bit, Stryker J-latch, 12 mm stop, 75 mm length

03.315.007 Pediatric Drill Guide, for 1.0 mm and 1.3 mm screws

03.315.008 Obturator for Pediatric Drill Guide




03.500.014 Cutting Instrument, for Distraction Footplates

03.503.039 Plate Cutter for Midface Plates


Instruments

312.154 1.5 mm Threaded Drill Guide, long, for 2.0 mm plates

1.5 mm/2.0 mm Screwdriver Blades,self-retaining, PlusDrive, hex coupling

313.252 96 mm313.253 76 mm

Screwdriver Blades, self-retaining, PlusDrive, hex coupling

313.806 1.3 mm, 76 mm314.485 1.0 mm, 75 mm

Cruciform Screwdriver Blades with Spring Holding Sleeve, hex coupling

314.482 1.0 mm314.491 1.3 mm314.651 1.5 mm314.675 2.0 mm

0.76 mm Drill Bits, Stryker J-latch, for use with 1.0 mm screws

316.114 with 14 mm stop, 44.5 mm 316.15 with 5 mm stop, 44.5 mm 316.18 with 8 mm stop, 44.5 mm


347.964 Combination Bending Pliers, for 1.0 mm and 2.0 mm Plates


316.235 60 mm316.446 with 4 mm stop, 44.5 mm316.447 with 6 mm stop, 44.5 mm316.448 with 8 mm stop, 44.5 mm


317.14 with 4 mm stop, 44.5 mm317.16 with 6 mm stop, 44.5 mm317.18 with 8 mm stop, 44.5 mm317.22 with 12 mm stop, 44.5 mm317.335 110 mm


317.64 with 4 mm stop, 44.5 mm317.66 with 6 mm stop, 44.5 mm317.68 with 8 mm stop, 44.5 mm317.72 with 12 mm stop, 44.5 mm317.835 110 mm

319.52 Depth Gauge, long, for 1.5 mm and 2.0 mm screws


Instruments

347.98 Plate Holding Forceps, for 1.5 mm, 2.0 mm and 2.4 mm plates

Plate Holding Instruments

347.986 for 1.0 mm and 1.3 mm plates347.987 for 1.5 mm and 2.0 mm plates

391.952 Mesh Cutter









CMF Distraction System Set (01.315.000)

Graphic Cases, Trays and Modules690.670 Graphic Case, for CMF Distractor

690.625 Basic Craniofacial Tray Insert

690.657 Orthognathic Trocar Tray Insert

690.672 Distraction Instrument Insert Tray, for CMF Distractor

304.071 BC Distractor Body/Extension Arm Module,for CMF Distractor

304.072 1.0 mm/1.3 mm Mandible Module, for CMF Distractor

304.073 1.5 mm Mandible Module, for CMF Distractor

304.074 2.0 mm Mandible Module, for CMF Distractor

304.089 AB Distractor Body Module, for CMF Distractor

Screw Length MarkersScrew Length Markers (10/pkg.)

304.104 4 mm

304.106 6 mm

304.108 8 mm

304.110 10 mm

304.112 12 mm

Screw Length Markers, for self-drilling screws304.104W 4 mm, 4 ea.

304.106W 6 mm, 6 ea.

304.108W 8 mm, 4 ea.

304.072

Note: For additional information, please refer to package insert.For detailed cleaning and sterilization instructions, please refer tohttp://us.synthes.com/Medical+Community/Cleaning+and+Sterilization.htmor to the below listed inserts, which will be included in the shipping container:– Processing Synthes Reusable Medical Devices—Instruments, Instrument Trays

and Graphic Cases—DJ1305– Processing Non-sterile Synthes Implants—DJ1304


* The CMF Distraction System Set is used with the Curvilinear Distractor.

Instruments03.307.002 Silicone Tip Guard, 6 ea.03.315.001 Activation Instrument, 1.7 mm, for CMF

Distractor, 2 ea.03.315.003 Alignment Rod, for CMF Distractor, 2 ea.03.315.004 Removal Instrument, for CMF Distractor03.315.005 Activation Instrument, 1.7 mm with U-Joint,

for CMF Distractor03.315.007 Pediatric Drill Guide, for 1.0 mm and

1.3 mm screws03.315.008 Obturator for Pediatric Drill Guide03.315.009 Cheek Retractor for Pediatric Drill Guide03.315.010 0.76 mm Drill Bit, Stryker J-latch,

14 mm stop, 75 mm length03.315.011 1.0 mm Drill Bit, Stryker J-latch, 12 mm stop,

75 mm length03.500.014 Cutting Instrument, for Distraction Footplates03.500.015* Crimping Instrument, for Curvilinear Distractor03.503.039 Plate Cutter for Midface Plates311.005 Screwdriver Handle with Hex Coupling, small311.006 Screwdriver Handle with Hex Coupling, medium312.154 1.5 mm Threaded Drill Guide, long,

for 2.0 mm plates

Screwdriver Blade, self-retaining, PlusDrive,hex coupling, 2 ea.

313.252 1.5 mm/2.0 mm, 96 mm313.253 1.5 mm/2.0 mm, 76 mm

Screwdriver Blade, self-retaining, PlusDrive, hex coupling, 2 ea.

313.806 1.3 mm, 76 mm314.485 1.0 mm, 75 mm

Cruciform Screwdriver Blade with Spring Holding Sleeve, hex coupling

314.482 1.0 mm314.491 1.3 mm314.651 1.5 mm314.675 2.0 mm


316.114 with 14 mm stop, 44.5 mm 316.15 with 5 mm stop, 44.5 mm316.18 with 8 mm stop, 44.5 mm


316.235 60 mm

316.446 with 4 mm stop, 44.5 mm

316.447 with 6 mm stop, 44.5 mm

316.448 with 8 mm stop, 44.5 mm


317.14 with 4 mm stop, 44.5 mm

317.16 with 6 mm stop, 44.5 mm317.18 with 8 mm stop, 44.5 mm

317.22 with 12 mm stop, 44.5 mm

317.335 110 mm, 2 ea.





317.72 with 12 mm stop, 44.5 mm

317.835 110 mm, 2 ea.

319.52 Depth Gauge, long, for 1.5 mm and 2.0 mmscrews

347.964 Combination Bending Pliers, for 1.0 mm and2.0 mm Plates

347.98 Plate Holding Forceps, for 1.5 mm, 2.0 mm and 2.4 mm plates

Plate Holding Instruments

347.986 For 1.0 mm and 1.3 mm plates

347.987 For 1.5 mm and 2.0 mm plates

391.952 Mesh Cutter









Implants04.315.000 2.7 mm Titanium Machine Screw,

for CMF Distractor, 3 ea.

04.315.001 Removable End Cap, for CMF Distractor, 2 ea.

AB Distractor Bodies, End Activated, for CMF Distractor, 2 ea.Length (mm)

04.315.003 1504.315.004 2004.315.005 2504.315.006 30

BC Distractor Bodies, End Activated, for CMF Distractor, 2 ea.Length (mm)

04.315.023 1504.315.024 2004.315.025 2504.315.026 3004.315.027 3504.315.028 40

AB Distractor Bodies, End Activated with U-Joint, for CMF Distractor, 2 ea.

Length (mm)04.315.053 1504.315.054 2004.315.055 2504.315.056 30

BC Distractor Bodies, End Activated with U-Joint, for CMF Distractor, 2 ea.

Length (mm)04.315.063 1504.315.064 2004.315.065 2504.315.066 3004.315.067 3504.315.068 40

Removable Extension Arms, rigid, 2 ea.Length (mm)

04.315.104 2004.315.108 4004.315.112 60

Removable Extension Arms, flexible, 2 ea.Length (mm)

04.315.125 3004.315.127 4004.315.132 60

1.0 mm Mandible Mesh Feet, for CMF Distractor, 3 ea.Style

04.315.201 A-Type04.315.202 B-Type04.315.203 C-Type

1.0 mm Mandible Cloverleaf Feet, for CMF Distractor, 3 ea.Style









1.2 mm Titanium Emergency Screws, with PlusDrive recess, 4 ea.

Length (mm)400.464E 4400.466E 6400.468E 8400.470E 10400.472E 12

1.3 mm Titanium Cortex Screws, self-drilling, with PlusDrive recess, 4 pkgs. of 5 ea.

Length (mm)400.454 4400.456 6

1.3 mm Titanium Cortex Screws, self-tapping, with PlusDrive recess (5/pkg.)

Length (mm) Qty. (Pkgs.)400.434 4 2400.436 6 2400.438 8 4400.440 10 2400.442 12 2

1.7 mm Titanium Emergency Screws, with PlusDrive recess

Length (mm) Qty.400.484E 4 6400.486E 6 6400.488E 8 4400.490E 10 2400.492E 12 2

1.5 mm Titanium Cortex Screws, self-drilling, with PlusDrive recess (5/pkg.)

Length (mm) Qty. (Pkgs.)400.054 4 2400.056 6 4400.058 8 4

Implants continued



1.5 mm Mandible Elevated Mesh Feet, 3 ea.Style Offset

04.315.321 B-Type 5.5 mm04.315.322 B-Type 7.5 mm04.315.323 C-Type





2.0 mm Mandible Elevated Mesh Feet, 3 ea.Style Offset

04.315.421 B-Type 5.5 mm04.315.422 B-Type 7.5 mm04.315.423 C-Type

1.0 mm Titanium Cortex Screws, self-tapping, with PlusDrive recess, 4 pkgs. of 5 ea.

Length (mm)400.404 4400.406 6400.408 8400.410 10400.412 12


2.0 mm Titanium Locking Screws, self-tapping, with PlusDrive recess (5/pkg.)

Length (mm) Qty. (Pkgs.)401.292 6 4401.294 8 4401.295 10 2401.296 12 2

2.4 mm Titanium Emergency Screws, with PlusDrive recess

Length (mm) Qty.401.791E 5 4401.792E 6 12401.794E 8 12401.795E 10 4401.796E 12 4



Length (mm) Qty. (Pkgs.)400.034 4 2400.036 6 4400.038 8 4400.040 10 2400.042 12 2

2.0 mm Titanium Emergency Screws, with PlusDrive recessLength (mm) Qty.

400.274E 4 4 400.276E 6 8400.278E 8 8400.280E 10 2400.282E 12 2

2.0 mm Titanium Cortex Screws, self-drilling, with PlusDrive recess (5/pkg.)

Length (mm) Qty. (Pkgs.)401.061 4 2401.063 6 4401.065 8 4


Length (mm) Qty. (Pkgs.)401.041 4 2401.043 6 4401.044 8 4401.045* 10 2401.046* 12 2

*Coarse pitch


References

1. Izadi K, Yellon R, Mandell DL, et al. “Correction of Upper Airway Obstruction in the Newborn with Internal Mandibular Distraction Osteogenesis.” J Craniofac Surg 14:493-499, 2003.

2. Mandell DL, Yellon R, Bradley J, et al. “Mandibular Distraction for Micrognathia and Severe Upper Airway Obstruction.” Arch Otolaryngol Head Neck Surg 130:344-348, 2004.

3. Steinbacher D, Kaban L, Troulis M. “Mandibular Advancement by Distraction Osteogenesis for Tracheostomy-Dependent Childrenwith Severe Micrognathia.” J Oral Maxillofac Surg 63:1072-1079,2005.

4. Ow A, Cheung L. “Meta-Analysis of Mandibular Distraction Osteogenesis: Clinical Applications and Functional Outcomes.”Plastic and Reconstructive Surgery 121: 54-69, 2008.

Synthes CMF1302 Wrights Lane EastWest Chester, PA 19380Telephone: (610) 719-5000To order: (800) 523-0322Fax: (610) 251-9056

Synthes (Canada) Ltd.2566 Meadowpine BoulevardMississauga, Ontario L5N 6P9Telephone: (905) 567-0440To order: (800) 668-1119Fax: (905) 567-3185

© 2008 Synthes, Inc. or its affiliates. All rights reserved. PlusDrive and Synthes are trademarks of Synthes, Inc. or its affiliates. Printed in U.S.A. 3/12 J7415-D

www.synthes.com

Documents

Craniomaxillofacial (CMF) Distraction System. A modular ...synthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes... · Distraction System is intended for use as a bone stabilizer and