5

1

3

4

2

6

Tecnica Spider – USA Doc Rev. 04 del 19/11/2012

mm

mm

mm

mm

5

1

3

4

2

6

Instruments set

Expander 20 mm 178 mm Ø 4.2 mm 1

Expander 25 mm 183 mm Ø 4.2 mm 1

Injection kit (for two voids) 2

Working cannula 137 mm Ø 5 mm 3

Reamer 20 mm 178 mm Ø 4.5 mm 4

Reamer 25 mm 183 mm Ø 4.5 mm 4

Guide wires 300 mm Ø 1.8 mm 5

Trocar 150 mm 11G 6

To send the order: Fax +39 02 45 79 02 66

Expander - length 20 mm SPS – 10N120

Expander - length 25 mm SPS – 10N125

Access kit - length 20 mm SPS – 25S420

Access kit - length 25 mm SPS – 25S425

Pedicle needle for bone cement - Ø 3,2 mm length 40 mm SPS – 26S540*

Pedicle needle for bone cement - Ø 3,2 mm length 45 mm SPS – 26S545*

Pedicle needle for bone cement - Ø 3,2 mm length 50 mm SPS – 26S550*

Pedicle needle for bone cement - Ø 4,1 mm length 40 mm SPS – 26S640*

Pedicle needle for bone cement - Ø 4,1 mm length 45 mm SPS – 26S645*

Pedicle needle for bone cement - Ø 4,1 mm length 50 mm SPS – 26S650*

CONTRAINDICATIONSContraindications to an implant of Sintea Plustek Spider are analogous to those of similar products currently available and include, but are not limited to:

ABSOLUTE:• Asymptomatic stable fractures.• Effective medical therapy.• Osteomyelitis in an injured vertebra or in a vertebra affected by repeated infections in an active stage.• Non-correctable coagulopathy.• Allergy to the components.• Patients who are either unwilling or unable to follow instructions.• Young patients or those having highly mineralized or sclerotic bones.

RELATIVE:• Radicular pain or radiculopathy caused by a compressive syndrome, not connected with vertebral fracture.• Posterior displaced fragment with vertebral duct damage over 20%.• Tumor extended inside the epidural space.• Severe compression of vertebral body (vertebra plana).• Symptomatic inveterate fracture.

If the use of Sintea Plustek Spider Kyphoplasty and Vertebroplasty System is considered the best solution for the patient and if the patient presents one or more of the above contraindications, it is essential that the patient is informed of the possible negative consequences that might hinder the success of the procedure.

Kyphoplasty and Vertebroplasty SystemThe products are supplied sterile

Kyphoplasty and Vertebroplasty System

www.sinteaplustek.com

Manufacturing Plant: Via Aquileia 33/H – 20021 Baranzate (MI) – ItalyPh. +39 02 45 79 02 31 Fax +39 02 45 79 02 66E-mail: info@sinteaplustek.com

Sintea Plustek LLC

407 Lincoln Rd. Suite 10/L33139 Miami Beach (FL) – USAPh. +1 305 67 36 226Fax +1 305 67 33 312E-mail: info@sinteaplustek.com

Sintea Plustek S.r.l.Commercial, administrative and registered office:Via E. Fermi 44 – 20090 Assago (MI) – ItalyPh. +39 02 45 79 02 31 – Fax +39 02 45 79 02 66E-mail: info@sinteaplustek.comVAT NO. 04874470968 - Fully paid up capital € 100.000,00 National Business Register: Milan (Italy) no. 1778805

SISTEMA DI GESTIONECERTIFICATO

UNI EN ISO 9001UNI EN ISO 13485

Expansion scale

1/3 2/3 3/3

Maximum Diameter

Expander 20 mm 5.6 mm 11.3 mm 17 mm

Expander 25 mm 6.3 mm 12.6 mm 19 mm

Maximum Length

Expander 20 mm 17.5 mm 15.5 mm 13.5 mm

Expander 25 mm 22.5 mm 20.5 mm 18.5 mm

Maximum Volume

Expander 20 mm 1cc 2cc 3cc

Expander 25 mm 1.5cc 3cc 4.5cc

*

* On request

using

Kyphoplasty and Vertebroplasty System

PEDICLE ENTRYIdentify the correct pedicle entry point by AP and LL C-Arm views. In order to facilitatethe trocar insertion, make a ~ l cm skin incision.Drive the trocar forward using a light hammer while monitoring the entry process with the C-Arm.In case of osteoporotic bone, proceed with precaution to prevent penetration into the anterior vertebral wall due to the scanty consistency. Choose the proper angle to either approach, transpedicular or para pedicular, according to the mono or bipedicularsurgical approach.The tip should be positioned 5 mm to l0 mm before the anterior margin of the vertebralbody.In order to prevent spinal cord and/or nerve root injury during this procedure, and to further achieve desired results, special care must be taken whilst completing this step.Remove the inner needle, leaving the trocar in place.

GUIDE WIRE POSITIONINGInsert the guide wire through the trocar. Forceps can be used, if necessary. Checkthe positioning of the wire by use of the C-Arm. Remove the trocar when the wire isin the correct position.

STEP 06

STEP 07

STEP 08

REAMER INSERTIONThe reamer is inserted into the working cannula and the target positioned: the 20mm reamer corresponds to the 20mm expander and the 25mm reamer corresponds to the 25mm expander. Typically, the 20mm reamer is used for thoracic vertebrae, whilethe 25mm reamer is used for lumbar vertebrae.Place the reamer into the guide wire and drill into the bone until the final position is reached by rotating the handle clockwise. Be sure that the reamer does not penetratethe anterior cortex of the vertebral body.The working cannula should maintain its position (approximately 2mm to 5mm anteriorto the spinal canal) during the removal process. Begin removing the guide wire, then extract the reamer.

CAVITY CREATIONInsert the expander until the target is introduced to the first notch and the white circle on the handle is aligned with the expander’s tip. At this point, turn the T-handle clockwi-se to expand the tip. The target should not be repositioned.The volume of the new cavity should be checked through the expansion graduated scale.(This allows a choice of three different sizes: 1/3, 2/3, or 3/3, full expansion).It is possible that the nitinol tip may deform due to high bone density of the area. This does not prevent the cavity formation or the overall completion of the surgical procedure.ATTENTION:1. DO NOT expand the Spider if the target is not fully engaged into the notch.2. DO NOT rotate an expanded device.3. X-Ray should be used to oversee the entire expansion process.4. Stop expansion process if the end plate is approached.

SPIDER CLOSING PROCEDURERotate the handle counter-clockwise until the device is completely closed. Retract the target from the first notch and insert into the second notch. Then repeat the procedureinto the next notches.The expansion process should be repeated through each of the five notches. Thus, utilizing the maximum capability of the device by ultimately generating a 360° cavity. Retain the position of the working cannula and extract the expander.

BONE CEMENTING INJECTIONPrepare the bone cement. Once the cement reaches the correct viscosity, insert it intothe working cannula. Care must be taken while injecting to obtain optimal cement filling.Continue the operation until the cavity is properly filled.Check the injection step by using the C-Arm.

As an alternative to the use of injection kits, in case of open surgeries, the prepared bone cement could be injected in the vertebral body by directly connecting the proper injector to the Pedicle Needle (Luer-Lock connection), inserting then the needle in the pedicle entry point.Check the injection step by using the C-Arm.WARNING: If the surgeon has to perform other procedures after the bone cement injection, such as pedicle screw insertion in the ce-mented vertebral body, refer carefully to bone cement Instructions for Use, keeping attention to the indicated working time.Considering the Sintea Plustek Sinplus S bone cement, for example, the time for the insertion of pedicle screws is about 7 minutes since the end of the mixing step.

STEP 08A

STEP 05