Thoracolumbar Spine Locking Plate (TSLP) System. A low-profile plating system for anterior stabilization of the thoracic and lumbar spine.

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1 Thoracolumbar Spine Locking Plate (TSLP) System. A low-profile plating system for anterior stabilization of the thoracic and lumbar spine. Technique Guide Instruments and implants approved by the AO Foundation

2 Table of Contents Introduction Thoracolumbar Spine Locking Plate (TSLP) System 2 AO Principles 4 Indications 5 Surgical Technique Decompress 6 Select Plate 7 Prepare to Implant Plate 8 Prepare Screw Hole 9 Measure for Screw Length 10 Insert Screws 11 Final Tightening 12 Optional Graft Screw Technique 13 Product Information Instruments 15 Set List 18 Image intensifier control Synthes Spine

3 Thoracolumbar Spine Locking Plate (TSLP) System The Thoracolumbar Spine Locking Plate (TSLP) is a versatile, low-profile plating system indicated for anterior stabilization of the thoracic and lumbar spine (T1 L5). The system provides a 4.5 mm construct profile, plate lengths from 40 mm to 109 mm in 3 mm increments, 5.5 mm cancellous locking screws, and instrumentation designed to simplify construct placement. 2 Synthes Spine Thoracolumbar Spine Locking Plate (TSLP) System

4 Plates Low profile (4.5 mm) Narrow AP width fits small vertebral bodies and minimizes surgical exposure and soft tissue disruption Precontoured to conform to the anatomy and restore normal spinal alignment Multiple screw hole locations Lengths in 3 mm increments (40 mm 109 mm) Convergent screw orientation maximizes resistance to construct pullout Conical screw holes allow ±5 angulation during screw insertion Made of titanium alloy (Ti -6Al -7Nb) for increased stiffness 5º 5.5 mm Titanium Cancellous Locking Screws Dual core thread design Constant outer diameter optimizes pullout strength Core diameter transition results in cortical and cancellous bone-specific threads Threads on conical screw head lock to the plate and create a fixed-angle construct Blunt, threaded tip Self-tapping design Cortical inner core diameter Transition Cancellous inner core diameter Constant outer diameter Synthes Spine 3

5 AO Principles In 1958, the AO ASIF formulated four basic principles, which have become the guidelines for internal fixation. 1 They are: Anatomic reduction Stable internal fixation Preservation of blood supply Early, active mobilization The fundamental aims of fracture treatment in the limbs and fusion of the spine are the same. A specific goal in the spine is returning as much function as possible to the injured neural elements. 2 AO Principles as Applied to the Spine 3 Anatomic alignment Restoration of normal spinal alignment to improve the biomechanics of the spine. Stable internal fixation Stabilization of the spinal segment to promote bony fusion. Preservation of blood supply Creation of an optimal environment for fusion. Early, active mobilization Minimization of damage to the spinal vasculature, dura, and neural elements, which may contribute to pain reduction and improved function for the patient. 1. M.E. Muller, M. Allgöwer, R. Schneider, and H. Willenegger: Manual of Internal Fixation, 3rd Edition. Berlin; Springer-Verlag Ibid. 3. M. Aebi, J.S. Thalgott, and J.K. Webb. AO ASIF Principles in Spine Surgery. Berlin; Springer-Verlag Synthes Spine Thoracolumbar Spine Locking Plate (TSLP) System

6 Indications The TSLP System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1 L5) spine instability resulting from fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery. Warnings: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. This device is not intended or expected to be the only mechanism of support for the spine. Regardless of the etiology of the spinal pathology for which implantation of this system was chosen, it is the expectation and requirement that a spinal fusion or arthrodesis be planned and obtained. Without solid biological support provided by spinal fusion, the device cannot be expected to support the spine indefinitely and may fall in any of several modes including bone-metal interface failure, screw fracture, or bone failure. Contraindications: Use of the Ti Thoracolumbar Spine Locking Plate (TSLP) System is contraindicated when: 1. There is active systemic infection, infection localized to the site of the proposed implantation, or when the patient has demonstrated allergy or foreign body sensitivity to any of the implant materials. 2. Severe osteoporosis may prevent adequate fixation and thus preclude the use of this or any other orthopaedic implant. 3. Metastatic tumors are present in the adjacent vertebral bodies. 4. Conditions that may place excessive stresses on bone and implants, such as severe obesity or degenerative disease are relative contraindications. The decision whether to use these devices under such conditions must be made by the physician taking into account the risks versus the benefits to the patient. Use of these implants is relatively contraindicated in patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to follow postoperative restrictions and who may place undue stresses on the implant during bony healing and may be at a higher risk of implant failure. Synthes Spine 5

7 Decompress 1 Decompress Perform the corpectomy/discectomy and decompress the neural elements as needed. 2 Implant graft or spacer Implant the graft or spacer device. Pack autograft or allograft material around the spacer as needed. 6 Synthes Spine Thoracolumbar Spine Locking Plate (TSLP) System

8 Select Plate 3 Select plate Instrument Measuring Forceps Use the measuring forceps to determine plate length. Select the proper plate. The labeled plate length is the overall length of the plate. Read measurement here 4 Verify size and position Instruments Threaded Drill Guide Construct Holder Assemble a threaded drill guide into one of the threaded screw holes in the plate. Insert the construct holder into the threaded drill guide and position the plate over the desired site. Position the plate so that the curve of the plate best follows the spinal curvature. Using the plate as a template, remove any bony protuberances that prevent the plate from sitting flush on the vertebral bodies, and determine which holes will be used to secure the plate to the vertebral bodies. Synthes Spine 7

9 Prepare to Implant Plate 5 Prepare to implant plate Instrument Threaded Drill Guide Attach threaded drill guides to all the selected screw holes. 6 Position plate Instruments Temporary Fixation Pins Detachable Temporary Fixation Pins Driver Position the plate anterolaterally on the spinal column, ensuring that all screws will be placed into vertebral bodies. Lag the plate to the bone by inserting temporary fixation pins, or detachable temporary fixation pins attached to the driver, through the threaded drill guides. Light impaction on the fixation pin may be necessary to break the cortex. To improve visibility, the construct holder and associated threaded drill guide can now be removed. 8 Synthes Spine Thoracolumbar Spine Locking Plate (TSLP) System

10 Prepare Screw Hole 7 Prepare screw hole Instruments Threaded Drill Guide Applicator Awl Insert the threaded drill guide applicator into one of the open threaded drill guides. The drill guide applicator will serve as a guide for the awl. Insert the awl through the drill guide applicator and perforate the bony cortex of the vertebral body. Light impaction may be necessary. The awl handle will stop at the top of the drill guide applicator when it is fully inserted. The awl creates a 20 mm deep hole. Note: The awl may also be used directly through the threaded drill guide. In this case the awl creates a 23 mm deep hole. Using the drill guide applicator, loosen the threaded drill guide and remove the awl/threaded drill guide applicator/ threaded drill guide assembly in one step. Tip: Prior to removal of the assembly, retract the awl until the etched line on the shaft is visible (approximately 30 mm). The tip of the awl will be withdrawn inside the drill guide applicator to protect the soft tissue during removal. Synthes Spine 9

11 Measure for Screw Length 8 Measure for screw length Instrument Depth Gauge Insert the depth gauge through the screw hole and push it through the cancellous bone to the desired depth. The depth gauge reading indicates the appropriate screw length. 9 Select screw Instruments mm Hexagonal Screwdriver, self-retaining mm Hexagonal Screwdriver Shaft Ratchet T-Handle Holding Sleeve Using the self-retaining 3.5 mm hexagonal screwdriver or the 3.5 mm hexagonal screwdriver shaft, ratchet T-handle, and holding sleeve, select the appropriate screw. Note: Screw length is measured from the beginning of the bone thread to the tip of the screw. 10 Synthes Spine Thoracolumbar Spine Locking Plate (TSLP) System

12 Insert Screws 10 Insert screws Insert the screw until the screw head engages the plate. Repeat steps 7 10 to insert the second screw. Note: It is recommended that the maximum screw length used in the anterior screw holes is 33 mm. 11 Remove temporary fixation pins Remove the temporary fixation pin(s) and then the threaded drill guide(s) using the drill guide applicator. Follow steps 8 10 to measure and insert the appropriate bone screws. Note: After removing a temporary fixation pin, use of the awl is not required before screw insertion. Remove any remaining drill guides. Synthes Spine 11

13 Final Tightening 12 Final tightening Instruments mm Hexagonal Screwdriver Shaft Torque Limiting Handle (7 Nm) For final tightening, use the 3.5 mm hexagonal screwdriver shaft with the torque limiting handle (7 Nm). 12 Synthes Spine Thoracolumbar Spine Locking Plate (TSLP) System

14 Optional Graft Screw Technique 13 Drill for graft screw Instruments Threaded Drill Guide mm Drill Bit Attach a threaded drill guide to the desired graft screw location. Using the 3.3 mm drill bit through the threaded drill guide, drill a hole into the graft. The 3.3 mm drill bit creates a 22 mm deep hole. Remove the threaded drill guide. 14 Tap for graft screw Instruments Ratchet T-Handle Tap for 5.5 mm Cancellous Locking Screws Use the tap for 5.5 mm cancellous locking screws and the ratchet T-handle to tap the drilled hole. Note: Take care to keep the tap centered in the threaded screw hole. Synthes Spine 13

15 Optional Technique continued 15 Insert graft screw Instrument Torque Limiting Handle Insert the graft screw into the tapped hole until the screw head locks to the plate. Use the torque limiting handle for final tightening. 14 Synthes Spine Thoracolumbar Spine Locking Plate (TSLP) System

16 Instruments Conical Extraction Screw, for 5.5 mm Locking Screws Handle, with quick coupling Depth Gauge Torque Limiting Handle, quick release mm Hexagonal Screwdriver, self-retaining Measuring Forceps Ratchet T-Handle Synthes Spine 15

17 Instruments continued Threaded Drill Guide Applicator Threaded Drill Guide Awl Temporary Fixation Pin mm Hexagonal Screwdriver Shaft, self-retaining mm Drill Bit, quick coupling, 248 mm 16 Synthes Spine Thoracolumbar Spine Locking Plate (TSLP) System

18 Construct Holder Tap for 5.5 mm Cancellous Locking Screws Holding Sleeve mm Hexagonal Screwdriver Shaft Driver, for Detachable Temporary Fixation Pin Detachable Temporary Fixation Pin Synthes Spine 17

19 Thoracolumbar Spine Locking Plate Instrument and Titanium Implant Set ( ) Graphic Case Graphic Case for Thoracolumbar Spine Locking Plate Instrument and Implant Set Instruments Conical Extraction Screw, for 5.5 mm locking screws, 2 ea Handle, with quick coupling Depth Gauge Torque Limiting Handle, quick release mm Hexagonal Screwdriver, self-retaining, 2 ea Measuring Forceps Ratchet T-Handle Threaded Drill Guide Applicator, cannulated, 2 ea Threaded Drill Guide, 6 ea Awl, for 3.3 mm hole Temporary Fixation Pin, 2 ea mm Hexagonal Screwdriver Shaft, self-retaining mm Drill Bit, quick coupling, 248 mm Construct Holder Tap for 5.5 mm Cancellous Locking Screws, 248 mm Holding Sleeve mm Hexagonal Screwdriver Shaft Driver, for Detachable Temporary Fixation Pin Detachable Temporary Fixation Pin, 4 ea. Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to or 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 DJ Synthes Spine Thoracolumbar Spine Locking Plate (TSLP) System

20 Implants 5.5 mm Titanium Cancellous Locking Screws, 4 ea. Thread Length mm mm mm mm mm mm mm mm mm mm mm mm mm Titanium Thoracolumbar Spine Locking Plates Length mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm Synthes Spine 19

21 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) Synthes, Inc. or its affiliates. All rights reserved. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 1/11 J4903-E

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