TELESCOPIC CORPECTOMY SYSTEM

TELESCOPIC CORPECTOMY SYSTEM

The simplified Vertebral Body Replacement Features of Thoraco-Lumbar TeCorp Modular endplates 3 colour coded endplates permit 9 possible angular combinations Safe support and anchorage in the vertebral endplates respect the adjacent vertebrae Large graft areas improve fusion rate In situ distraction allows precise adjustement of the implant height Secure locking mechanism maintains the distracted implant height (1mm increment) 2

The titanium TeCorp VBR system implanted via the anterior or anterolateral approach is designed to replace the vertebral body at the cervical, thoracic or lumbar level. This VBR system allows the restoration of the intervertebral height as well as lordosis (at the cervical and lumbar level) and kyphosis (at the thoracic level). Indications include pathologies which require vertebral reconstruction such as: vertebral tumors anterior column fractures Features of Cervical TeCorp In-built variable cervical endplate allows lordosis angulation from 0 to 7 Posterior wall avoids graft migration and prevents damage to the canal and surrounding tissues Only two steps for in situ distraction and locking system 3

Surgical protocol for the cervical spine 1 Patient positioning/anterior approach The procedure is performed under general anesthesia. The patient is placed in dorsal decubitus, the approach is left or right pre-sterno-cleido-mastoid according to the surgeon s preference. 2 Discectomy and corpectomy First, a discectomy above and below the affected area is performed, followed by a corpectomy using the usual instruments. According to the pathology, the posterior longitudinal ligament (PLL) may also be resected as well as posterior vertebral osteophytes adjacent to the corpectomy performed. 3 Determining the intervertebral distance Once the decompression is finished, the measurement of the intervertebral distance is estimated using the measuring device. This will enable implant height to be chosen. 4 Implant choice Cervical TeCorp device diameter is 16 mm, different heights are available: 20 mm to 25 mm 26 mm to 37 mm 38 mm to 61 mm 4 Intervertebral measuring device 20PAC01

5 Positioning the implant Before positioning the implant on the parallel distractor it is important to lock the implant. This secures the implant on the parallel distractor prior to insertion. The choosen implant is placed into the space created by the corpectomy and correctly positioned. This is important in order to achieve optimal reduction and stabilization. The implant is then unlocked with the screwdriver and distracted in situ. Distraction is maintained while turning the locking screw. For precise positioning and reduction of the cervical spine, the angulation of the upper integrated endplate can be adjusted in situ. 6 Associated osteosynthesis It is recommended to add an osteosynthesis plate with the cervical TeCorp device such as the low profile cervical Stella plate. 7 Closing the approach Closure is as usual with suction drainage. Parallel distractor for cervical corpectomy implant 20DST01 / 21EDC01 Graft compactor 22COM05 Screwdriver for corpectomy implants 22TRV10 5

Surgical protocol for the thoracic spine To simplify the surgical technique, we have deliberately chosen a right thoracotomy. The lumbar vertebral reconstruction is technically similar except for the approach which consists in a median or lateral retroperitoneal postero-lumbar incision. 1 Patient positioning The procedure is performed under general anaesthesia, the patient is ventilated with a doublelumen tube. The patient is placed in left lateral decubitus position, thus thoracotomy is performed to access the thoracic spine. 2 Discectomy and corpectomy Lesion level is located, corpectomy is performed using the usual instrumentation, assuring proper decompression of the vertebral canal. 6

3 Implant choice and modular endplates Implant choice is determined by the extent and level of the corpectomy. A range of implant sizes is available: Thoracic TeCorp, diameter 21 mm 21 mm to 27 mm 27 mm to 39 mm 39 mm to 63 mm Lumbar TeCorp, diameter 27 mm 28 mm to 40 mm 40 mm to 64 mm Customization of the implant to suit the individual patient can be achived by the addition of the modular endplates which can be used in combinations that can create angles from 0 to 14. 4 Endplates orientation According to approach choice, endplates may be oriented by successive 18º rotations to restore spinal curvature. 18 36 54 0 5 7 Endplate holder for thoracic and lumbar corpectomy implants 22PRE13 Endplates 12PICxx-x 7

5 Positioning the implant The thoracic TeCorp device is firstly locked before being placed on the parallel distractor. This secures the implant on the instrument. + Note: In case of a left thoracotomy, the implant must be placed upside down in order to respect the appropriate position of the posterior wall protecting the surrounding tissus. After introduction into the corpectomy space the implant is unlocked and distracted until correct placement has been achieved and kyphosis normalised. Correction may be controlled by direct visualisation or fluoroscopically. Distraction is maintained while turning the locking screw with the screwdriver. 6 Associated osteosynthesis It is recommended that thoracic and lumbar TeCorp devices are stabilized with an osteosynthesis system such as the antero-lateral stabilization Lyra plate. 7 Closing the approach Closure is as usual with suction drainage. 8 Parallel distractor for thoracic and lumbar corpectomy implants 20DST01/22EDT01/22EDL01 Graft compactor 22COM05 Screwdriver for corpectomy implants 22TRV10

Do not use if package is Non Date of damaged sterile Sterile Manufacture Manufacturer Do not Read IFU Use only re-use

Implants Corpectomy implants Color code Height (mm) Ref. Cervical implant Ø 16 mm gold from 20 to 25 from 26 to 37 from 38 to 64 11ICC16-20 11ICC16-26 11ICC16-38 Thoracic implant Ø 21 mm green from 21 to 27 from 27 to 39 from 39 to 63 12ICT21-24 12ICT21-30 12ICT21-42 Lumbar implant Ø 27 mm blue from 28 to 40 from 40 to 64 12ICT27-31 12ICT27-43 Endplates For thoracic implant For lumbar implant Color code Angle Maximum height (mm) Ref. purple 7 3.6 12PIC21-7 gold 5 2.8 12PIC21-5 silver 0 1 12PIC21-0 purple 7 4.3 12PIC27-7 gold 5 3.4 12PIC27-5 silver 0 1 12PIC27-0 Instruments Ref. Parallel distractor for corpectomy implants Cervical tips for parallel distractor Thoracic tips for parallel distractor Lumbar tips for parallel distractor Endplate holder for thoracic and lumbar corpectomy implants Graft compactor Intervertebral measuring device Screwdriver for corpectomy implants Screwdriver for cervical corpectomy implants 20DST01 21EDC01 22EDT01 22EDL01 22PRE13 22COM05 20PAC01 22TRV10 21TRV08* * On request. Delivery time to be confirmed with order. 11

ALPHATEC SPINE, INC. 5818 El Camino Real Carlsbad, CA 92008 - U.S.A. TL +1 460 431 9286 www.alphatecspine.com SCIENT X-ALPHATEC SPINE 22, avenue Jean Bart 78960 Voisins-le-Bretonneux - FRANCE TL +33 (0)1 39 30 69 30 - FX +33 (0)1 30 43 82 77 www.scientx.com This product is not available for sale in the United States of America. Non contractual pictures. Please read carefully the instructions for use bulletin. Devices may be subject to modification. Patented. TeCorp & Scient x-alphatec Spine logo are trademarks of Alphatec Spine, Inc. (C) 2011 Alphatec Spine, Inc. All rights reserved. DOMKT507 en Rev1.0 - DMQ#11-315 - Approval date: August 2011