CSLP Variable Angle. For Use with the Cervical Spine Locking Plate System TECHNIQUE GUIDE. Self-drilling Screw. Variable Screw Angulation

Transcription

1 CSLP Variable Angle For Use with the Cervical Spine Locking Plate System TECHNIQUE GUIDE Self-drilling Screw Variable Screw Angulation Original Instruments and Implants of the Association for the Study of Internal Fixation AO/ASIF

2 Technique Options Implant Selection page 4 Unicortical Screw Purchase Bicortical Screw Purchase Self-Drilling Screws Self-Tapping Screws Bicortical Screws Variable Medial Angulation page 5 Variable Medial Angulation page 6 Bicortical Screw Purchase page 8 Lock Construct page 10 Self-Drilling Screws Self-Tapping Screws Bicortical Screws 12 mm 14 mm 16 mm 12 mm 14 mm 16 mm 18 mm 19 mm 20 mm

3 Table of Contents Features Technique Implant Selection and Preparation Self-Drilling Screws Variable Medial Angulation Self-Tapping Screws Variable Medial Angulation Bicortical Screw Purchase Technique Using Bicortical Screws Lock Construct Insert Locking Screws Product Information Instruments CSLP Instrument Set CSLP Variable Angle Plates CSLP Screws Inside Back Cover

4 CSLP Variable Angle The CSLP Variable Angle is designed to ease the surgical technique and increase system versatility, while maintaining the mechanical properties of the existing Cervical Spine Locking Plate. 1 Level 2 Level 3 Level 4 Level Variable Screw Angulation The screw can be angulated in any direction and still lock to the plate. This provides the stability and load sharing needed to allow bony fusion. The locking mechanism relies on the expansionhead screws, which have been proven effective in over 150,000 procedures. Self-Drilling Screws Self-drilling screws make drilling unnecessary. They have the same pull-out strength as selftapping and standard screws of the same size. 12 mm 14 mm 16 mm 2 The Synthes Anterior CSLP System including the Small Stature Anterior Cervical Vertebrae Plate System consists of plates with and Locking Screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine. The CSLP system listed systems are intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: spondylolisthesis, fracture, spinal stenosis, and tumor.

5 CSLP Variable Angle (continued) Additional Features Pre-lordosed plates Back surface of plate textured to reduce slippage Longer screw lengths allow bicortical screw purchase Available for 1-, 2-, 3- and 4-level corpectomies and discectomies A notch at each end of the plate allows space for pins when used to compress the graft. Bicortical screws (green) 18 mm, 19 mm, 20 mm Compatible with CSLP Variable Angle Standard 4.0 mm Cortex Screws 4.35 mm Cancellous 12 mm 14 mm 16 mm 18 mm 19 mm 20 mm Self-Tapping 4.0 mm Cortex Screws 4.0 mm Cancellous 4.35 mm Cancellous 4.5 mm Cancellous Self-Drilling 4.0 mm Cortex Screws 4.0 mm Cancellous 4.5 mm Cancellous Recommended for use Not available 3

6 Technique Implant Selection and Preparation 1 Select and insert graft Following approach and decompression, measure for graft, using the Caliper [324.06]. Insert the graft. For recommended grafting technique, refer to the Synthes ACF Spacer Technique Guide Measure for graft size using Caliper [324.06]. 2 Select plate Select a template of the estimated length. Place it on the vertebral body to determine plate length and screw position relative to the endplates. After plate length has been determined, ensure that the pre-lordosed plate fits the anatomy. Plate contour can be adjusted by using the Universal Bending Pliers [ ] Note: Repeated bending may weaken the plate. Note: Before inserting the plate, ensure that all bushings are in the correct position (the countersunk hole and four slots of the bushing should be visible from the top of the plate). Determine plate length using template [350.xxx] Increase lordotic bend Decrease lordotic bend Bushing allows variation of screw angle. 4

7 Technique Using Self-Drilling Screws With Variable Medial Angulation Steps 1 and 2 are shown on page 4. 3 Place plate Using the Plate Holder [ ], place the plate in the desired position on the vertebral body If desired, hold the plate in place with a Temporary Fixation Pin [ ]. The pin can be inserted with the Self-Retaining Screwdriver for expansionhead screws [ ]. Place plate and insert Temporary Fixation Pin [ ]. Temporary Fixation Pin 4 Break cortex Insert the Awl [ ] through the bushing in the desired screw trajectory and break the cortex. Push to stop (10 mm). The Awl centers the screw hole in the plate. Tip of awl Insert self-drilling expansionhead screws Load the appropriate length self-drilling screw onto the Self-Retaining Screwdriver for expansionhead screws. Insert the screw through the plate hole in the desired direction, until the head is seated in the bushing. Note: The head of the screw will be flush with the top surface of the bushing. Remove the temporary fixation pin and insert the remaining expansionhead screws. Break cortex using the Awl. Insert self-drilling expansionhead screw. 6 Lock construct Insert locking screws as described on page 10. Insert remaining expansionhead screws. 5

8 Technique Using Self-Tapping Screws With Variable Medial Angulation Steps 1 and 2 are shown on page 4. 3 Place plate Insert the Single Locking Drill Guide [ ] into the screw hole and squeeze the handles to lock it to the plate. Next slide the thumb-latch forward to keep the guide locked in place. Place the plate on the vertebra. If desired, hold the plate in place with a Temporary Fixation Pin [ ]. The pin can be inserted with the Self-Retaining Screwdriver for expansionhead screws [ ] Insert Single Locking Drill Guide into screw hole Squeeze handle, then slide thumb-latch forward Push forward Place plate and insert Temporary Fixation Pin [ ]. 4 Drill Angulate the drill guide in the desired direction and drill, using a silver-colored 3.0 mm Drill Bit [ ] of the appropriate length. Release the thumb-latch and remove the drill guide Pull back Drill using a 3.0 mm drill bit [ ]. To remove Single Locking Drill Guide from plate: Squeeze handle, pull thumb-latch back and release the handle. 6

9 Self-Tapping Screws With Variable Medial Angulation (continued) 5 Insert self-tapping expansionhead screw Insert a self-tapping expansionhead screw with the Self-Retaining Screwdriver for expansionhead screws [ ]. If desired, or when using non self-tapping screws, the drilled hole may be tapped using the appropriate tap [ ] Insert self-tapping expansionhead screw. Remove the Temporary Fixation Pin. Drill the remaining screw holes and insert the expansionhead screws. Insert remaining expansionhead screws. 6 Lock construct Insert locking screws as described on page 10. 7

10 Technique Using Bicortical Screws Steps 1 and 2 are shown on page 4. 3 Place plate Insert the Single Locking Drill Guide [ ] into the screw hole and squeeze the handles to lock it to the plate. Slide the thumb-latch forward to keep it locked in place. Place the plate on the vertebra Push forward If desired, hold the plate in place with a Temporary Fixation Pin [ ]. The pin can be inserted with the Self-Retaining Screwdriver for expansionhead screws [ ]. Insert Single Locking Drill Guide into screw hole Squeeze handle, then slide thumb-latch forward Place plate and insert Temporary Fixation Pin [ ]. 4 Drill Drill to the desired depth, using the 3.0 mm Drill Bit for Bicortical Screws [ ]. Confirm position under imaging. Release the thumb-latch and remove the drill guide Pull back Drill using the bicortical drill bit. To remove Single Locking Drill Guide from plate: Squeeze handle, pull thumb-latch back and release the handle. 8

11 Bicortical Screws (continued) 5a Select screw Use the Cervical Depth Gauge [ ] to measure for screw length. Read the length from the depth gauge and select the expansionhead screw of the same length Note: Length indicated on the depth gauge is the same as expansionhead screw length. Measure for screw length. 5b Insert expansionhead screw Insert the selected bicortical expansionhead screw using the Self-Retaining Screwdriver Remove the Temporary Fixation Pin. Drill remaining holes, measure and insert the remaining expansionhead screws using the same technique. 6 Lock construct Insert locking screws as described on page 10. Insert self-tapping expansionhead screw. Drill remaining screw holes through the drill guide, measure, and insert remaining expansionhead screws, using the same technique. 9

12 Lock Construct 6 Insert locking screws Use the Self-Retaining Screwdriver for locking screw [ ] to insert the 1.8 mm Locking Screws [497.78] into the expansionhead screws. The locking screw expands the flanges of the expansionhead screw, which expands the bushing and locks the screw in the plate. Note: To obtain the most rigid construct, the Countertorque Wrench [ ] should be used with the Self-Retaining Screwdriver for locking screw to provide countertorque during insertion and tightening of the locking screw. The tips of the countertorque wrench fit into the slots of the expansionhead screw head Insert the locking screws. Final construct 10

13 Instruments Single Locking Drill Guide [ ] Used as drill guide, and as a plate holder. With CSLP Variable Angle, it also allows variable screw angulation in all planes. 3.0 mm Drill Bit with stop, 12 mm 16 mm [324.12, , ] (silver) For use with the Single Locking Drill Guide [ ]. Caution: These drill bits should not be used with the Drill and Screw Guide [ ], as they do not provide a safety stop. Awl for self-drilling screws [ ] Used to center the screw hole in the plate and to break the near cortex. Tip of awl Cervical Depth Gauge [ ] For determining the correct length of bicortical screws. 11

14 Instruments (continued) 3.0 mm Drill Bit for Bicortical Screws [ ] For use only with CSLP Variable Angle. Note: This drill bit has a safety stop of 20 mm when used with the Single Locking Drill Guide [ ]. Caliper [324.06] For sizing graft. Plate Lifter [ ] For lifting CSLP plates out of modules [ , , , , ]. Temporary Fixation Pin [ ] Holds any Cervical Spine Locking Plate securely to the bone prior to final placement of screws. Compatible for use with Self-Retaining Screwdriver, for expansionhead screws [ ]. Countertorque Wrench [ ] Used with the Self-Retaining Screwdriver for locking screw [ ] to provide countertorque to the expansionhead screw during insertion and tightening of a locking screw. Note: Do not use for insertion and removal of expansionhead screws. 12

15 Taps [ ] Used to tap drilled holes for expansionhead screws. Self-Retaining Screwdriver, for expansionhead screws [ ] For insertion of expansionhead screws. May also be used to insert the Temporary Fixation Pin [ ]. Self-Retaining Screwdriver, for locking screw [ ] For inserting the locking screw into the expansionhead screw. Universal Plate Bender [ ] For contouring of CSLP plates. Caution: Repeated bending will weaken plate. Increase lordotic bend Decrease lordotic bend 13

16 Instruments (continued) Cervical Plate Holder [ ] Holds any CSLP plate during insertion and fixation. Handle with quick coupling [ ] For use with drill bits and conical extraction screw. Conical Extraction Screw [387.34] For removal of an expansionhead screw, if necessary. 14

17 Cervical Spine Locking Plate Instrument Set [ ] CSLP Graphic Case Instruments Caliper Countertorque Wrench mm Drill Bit with Stop, 12 mm, 2 ea mm Drill Bit with Stop, 14 mm, 2 ea mm Drill Bit with Stop, 16 mm, 2 ea Tap for 4.0 mm Cortex Tap for 4.0 mm Cancellous Self-Retaining Screwdriver for expansionhead screws, 2 ea Self-Retaining Screwdriver for locking screw, 2 ea Single Locking Drill Guide Awl for Self-Drilling Universal Plate Bender Conical Extraction Screw Plate Holder Temporary Fixation Pin for use with screwdriver, 3 ea Handle with quick coupling, 2 ea CSLP Graphic Case Also Available Locking Drill Guide with Tissue Protection Sleeve Cervical Plate Bender Plate Lifter mm Drill Guide Tap for 4.35 mm Cancellous Tap for 4.5 mm Cancellous Cervical Depth Gauge mm Drill Bit for Bicortical Screws 15

18 CSLP Variable Angle Implant Set [ ] Module Case for 1-,2-, and 3-Level Plates [ ] Module Case for 4-level Plates [ ] Plate Lifter for CSLP [ ] Cephalad to Overall caudal hole pair length length (mm) (mm) One-Level Plates Two-Level Plates Cephalad to Overall caudal hole pair length length (mm) (mm) Four-Level Plates Three-Level Plates Implants are commercially pure (CP) titanium Set also includes corresponding templates [ ] 16

19 CSLP Screws CSLP Screw Module [ ] (Holds six Screw Rack Inserts) Standard 4.0 mm Cortex mm mm mm 4.35 mm Cancellous mm mm mm Locking Screw mm Self-Drilling 4.0 mm Cortex mm mm mm 4.0 mm Cancellous mm mm mm 4.5 mm Cancellous mm mm mm Self-Tapping 4.0 mm Cortex mm mm mm 4.0 mm Cancellous mm mm mm 4.35 mm Cancellous mm mm mm Screw Rack Insert shown with screws Screw Rack Inserts (must be ordered separately) For Standard T1 4.0 mm Cortex T mm Cancellous Also Available Module case for CSLP Standard Plates 5, 8 and 9 holes For Self-Drilling T3 4.0 mm Cancellous T5 4.0 mm Cortex T9 4.5 mm Cancellous 4.5 mm Cancellous mm mm mm mm mm mm 4.0 mm Cortex, for bicortical use* mm* mm* mm* For Self-Tapping T2 4.0 mm Cortex T4 4.0 mm Cancellous T mm Cancellous T8 4.5 mm Cancellous * Longer lengths for bicortical purchase may be stored in flip-up screw rack of module.

20 SYNTHES Spine 1302 Wrights Lane East West Chester, PA Telephone: (610) To order: (800) Fax: (610 ) SYNTHES (CANADA) LTD Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) To order: (800) Fax: (905) Original Instruments and Implants of the Association for the Study of Internal Fixation AO/ ASIF 2000 SYNTHES Spine SYNTHES and ASIF are trademarks of SYNTHES (USA). Printed in U.S.A. Rev. 7/06 J3173-D