SURGICAL TECHNIQUE GUIDE TRESTLE Anterior Cervical Plating System
2 SURGICAL TECHNIQUE GUIDE
SURGICAL TECHNIQUE GUIDE System Features Large window enables visualization of graft site and end plates Screw heads fit flush maintaining the low-profile design and uniform surface Simple zero-step locking mechanism at each level is designed to minimize operative time Pre-contoured plates help simplify surgical procedure Contents Surgical Technique...4-9 Instruments...10-11 Implant Features... 12 Parts List...13-14 Product Information... 15 3
SURGICAL TECHNIQUE GUIDE Select Plate Select the appropriately sized plate. Trestle Plate Dimensions (in millimeters) Available in sizes 10mm - 100mm (2mm increments) Plates Length* I 10 12 14 16 18 20 22 24 26 Level II 24 26 28 30 32 34 37 40 43 46 III 39 42 45 48 51 54 57 60 63 66 69 IV 60 64 68 72 76 80 84 V 85 90 95 100 *Note: Plate length is measured from most superior hole center to most inferior hole center Included in set components Trial Position Plate Confirm plate position (lateral fluoroscopy may be helpful) Contour Plate () The Trestle plate is precountoured with 6 lordosis. Should additional contouring be required, the plate must be contoured in the middle of the graft window to the desired degree of lordosis. 4
Insert plate into Plate Bender as shown. Rotate plate on hammer with Blocking Slide facing down toward anvil. When contouring the plate, care should be taken not to scratch, notch or dent the surface of the plate or Blocking Slide, as the implant strength may be compromised. Contouring along the graft window, starting from outer edge working inward helps ensure an even contour of the plate. Note: Plates 28mm or shorter should not be contoured. Caution: Do not place Plate Bender over Blocking Slide. 5
SURGICAL TECHNIQUE GUIDE Position Plate Ensure the plate is properly aligned with respect to the end plates. Use Temporary Fixation Pins to hold the plate stationary for screw placement. Both self tapping and self drilling screws are available. If needed, a disposable tap is available in the instrument set. Create Screw Hole When using self drilling screws, first place Awl over screw hole and lightly tap through the cortical surface to create a pilot hole. If using the Self Constrained Awl, place Awl into screw hole and push down on Awl handle to create a punch through the cortical bone. The surgeon must take great care to properly position bone screw holes when using the Variable Drill Guide or Self Constrained Awl. Excessively converging hole patterns may prohibit proper seating of the bone screws. Hole patterns angled beyond 9 may prohibit proper seating of the bone screws. Note: The Fixed Angle Drill Guide is color coded with blue and gold on shaft. The Variable Angle Drill Guide is color coded with magenta and green on shaft. Drill Hole Select the corresponding color coded Drill Guide based on the type of screw selected (fixed or variable angle). When using self tapping screws, place the Drill Guide tip into the screw hole. Apply light pressure to fully seat the Drill Guide. Drill hole to appropriate depth. 6
Drill Guide Insertion Technique The tip of the Drill Guide must be placed under the Blocking Slide. A roll-in technique is recommended. Place the Drill Guide at an angle to the plate with the shaft of the guide crossing the midline of the plate. Insert the tip of the Drill Guide beneath the locking mechanism. Move the shaft of the Drill Guide laterally until the tip is fully seated beneath the locking mechanism. Once hole has been created, disengage the Drill Guide by angling the shaft across the midline of the plate. 7
SURGICAL TECHNIQUE GUIDE Temporary Fixation Pin Place Screws Insert screws with the Parallel Screwdriver. Advance each screw until it seats completely inside the screw hole. The axis of the Parallel Screwdriver must be aligned vertically over the axis of the screw. An axial (straight down) force must be applied when threading the screw into place. While advancing the screw, the Blocking Slide will move medially. With the screw fully inserted and the Parallel Screwdriver removed, the Blocking Slide will return to centered position as illustrated. To remove screw, refer to screw removal technique on page 9. Not Aligned Aligned Verify Alignment Ensure that the screws are fully seated and the vertical locking line is in direct alignment with the tip of reference arrows. To re-position the Blocking Slide, place the Slider Alignment Tool in a vertical orientation over the screw head. Manually rotate the alignment tool until the arrows on the Trestle plate are aligned with the line on the Blocking Slide. Inspect Plate Position Ensure arrows are completely aligned with the line on the locking mechanism. Check the final position of the plate and screws both visually and radiographically. 8
Screw Removal Place the Screw Removal Tool (without the Inner Shaft) perpendicular to the screw head and insert the tip of the Screw Removal Tool into the screw head. Ensure that the opening on the distal tip of the Screw Removal Tool is facing toward the Blocking Slide. Thread the Screw Removal Tool Inner Shaft through the cannula of the Screw Removal Tool. Ensure the tip of the Inner Shaft is fully seated in the screw head and then proceed to tighten the Inner Shaft. Rotate the Screw Removal Tool counterclockwise to move the Blocking Slide and continue on rotating in a counterclockwise direction until the screw is removed. 9
INSTRUMENTS 8mm Awl with Stop Parallel Screwdriver 8mm Awl for use with Drill Guide Slider Blocking Slide Alignment Tool Quick-Connect Handle Self-Constrained Awl Variable Angle Drill Guide Fixed Angle Drill Guide 10
Plate Holder Plate Bender Temporary Fixation Pin Screw Removal Tool Inner Shaft Screw Removal Tool 11
IMPLANT FEATURES Screw Features Smooth surface for patient comfort Pre-contoured lordosis Screws are color coded by type (self drilling and self tapping) and are available in both fixed and variable angles to allow for use in a wide variety of applications Self Drilling Screws Large graft window for optimal visualization Allow for single step fixation to optimize efficiency Self Tapping Screws 16mm wide 2.3mm thin Proprietary zero-step self-locking mechanism Offer intraoperative surgical options and reduce the number of steps to place the screw Material Radially contoured with 6º of medial angulation at all screw holes Titanium alloy Low Profile The screw head sits flush within the plate when completely inserted to maintain a slim profile Thread Sizes Standard screws (4.0mm diameter) Cephalad/Caudal Medial/Lateral Rescue screws (4.5mm diameter) Lengths 10mm - 26mm (2mm increments) Angular Variations Fixed angle screws offer 9 cephalad or caudal offset and 6 medial offset 9 offset 18 variability 15 variability 6 offset Variable angle screws provide 18 of cephalad/caudal variability from neutral angle and 15 of medial/lateral variability from neutral angle 12
PARTS LIST Plates are measured hole center to hole center Description Caddy Quantity 5 Level Plates 4 Level Plates 3 Level Plates 2 Level Plates 1 Level Plates 10mm 1 Level Plate 1 12mm 1 Level Plate 1 14mm 1 Level Plate 2 16mm 1 Level Plate 2 18mm 1 Level Plate 2 20mm 1 Level Plate 1 22mm 1 Level Plate 1 24mm 1 Level Plate 1 26mm 1 Level Plate 1 24mm 2 Level Plate 1 26mm 2 Level Plate 1 28mm 2 Level Plate 2 30mm 2 Level Plate 2 32mm 2 Level Plate 2 34mm 2 Level Plate 2 37mm 2 Level Plate 2 40mm 2 Level Plate 1 43mm 2 Level Plate 1 46mm 2 Level Plate 1 39mm 3 Level Plate 1 42mm 3 Level Plate 1 45mm 3 Level Plate 1 48mm 3 Level Plate 1 51mm 3 Level Plate 1 54mm 3 Level Plate 1 57mm 3 Level Plate 1 60mm 3 Level Plate 1 63mm 3 Level Plate 1 66mm 3 Level Plate 1 69mm 3 Level Plate 1 60mm 4 Level Plate 64mm 4 Level Plate 68mm 4 Level Plate 72mm 4 Level Plate 76mm 4 Level Plate 80mm 4 Level Plate 84mm 4 Level Plate 85mm 5 Level Plate 90mm 5 Level Plate 95mm 5 Level Plate 100mm 5 Level Plate 13
PARTS LIST TRESTLE 4.0mm Self Drilling Screws Description Caddy Quantity 4.0mm x 10mm Self-Drilling Variable Angle Screw 6 4.0mm x 12mm Self-Drilling Variable Angle Screw 12 4.0mm x 14mm Self-Drilling Variable Angle Screw 12 4.0mm x 16mm Self-Drilling Variable Angle Screw 12 4.0mm x 18mm Self-Drilling Variable Angle Screw 4.0mm x 20mm Self-Drilling Variable Angle Screw 4.0mm x 10mm Self-Drilling Fixed Angle Screw 6 4.0mm x 12mm Self-Drilling Fixed Angle Screw 12 4.0mm x 14mm Self-Drilling Fixed Angle Screw 12 4.0mm x 16mm Self-Drilling Fixed Angle Screw 12 4.0mm x 18mm Self-Drilling Fixed Angle Screw 4.0mm x 20mm Self-Drilling Fixed Angle Screw TRESTLE 4.0mm Self Tapping Screws Description Caddy Quantity 4.0mm x 10mm Self-Tapping Variable Angle Screw 6 4.0mm x 12mm Self-Tapping Variable Angle Screw 12 4.0mm x 14mm Self-Tapping Variable Angle Screw 12 4.0mm x 16mm Self-Tapping Variable Angle Screw 12 4.0mm x 18mm Self-Tapping Variable Angle Screw 4.0mm x 20mm Self-Tapping Variable Angle Screw 4.0mm x 10mm Self-Tapping Fixed Angle Screw 6 4.0mm x 12mm Self-Tapping Fixed Angle Screw 12 4.0mm x 14mm Self-Tapping Fixed Angle Screw 12 4.0mm x 16mm Self-Tapping Fixed Angle Screw 12 4.0mm x 18mm Self-Tapping Fixed Angle Screw 4.0mm x 20mm Self-Tapping Fixed Angle Screw 4.0mm x 22mm Self-Tapping Fixed Angle Screw 4.0mm x 24mm Self-Tapping Fixed Angle Screw 4.0mm x 26mm Self-Tapping Fixed Angle Screw TRESTLE 4.5mm Self Tapping Rescue Screws 14 Description Caddy Quantity 4.5mm x 10mm Self-Tapping Variable Angle Screw 6 4.5mm x 12mm Self-Tapping Variable Angle Screw 6 4.5mm x 14mm Self-Tapping Variable Angle Screw 6 4.5mm x 16mm Self-Tapping Variable Angle Screw 6 4.5mm x 18mm Self-Tapping Variable Angle Screw 4.5mm x 20mm Self-Tapping Variable Angle Screw 4.5mm x 10mm Self-Tapping Fixed Angle Screw 6 4.5mm x 12mm Self-Tapping Fixed Angle Screw 6 4.5mm x 14mm Self-Tapping Fixed Angle Screw 6 4.5mm x 16mm Self-Tapping Fixed Angle Screw 6 4.5mm x 18mm Self-Tapping Fixed Angle Screw 4.5mm x 20mm Self-Tapping Fixed Angle Screw 4.5mm x 22mm Self-Tapping Fixed Angle Screw 4.5mm x 24mm Self-Tapping Fixed Angle Screw 4.5mm x 26mm Self-Tapping Fixed Angle Screw
PRODUCT INFORMATION TRESTLE ANTERIOR CERVICAL PLATING SYSTEM GENERAL INFORMATION: The TRESTLE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. Implant plates and bone screws are manufactured from surgical grade titanium alloy (ASTM F136). All device components are intended for fixation/attachment to the anterior cervical spine only. It is intended that the implants be removed after successful fusion. WARNINGS: 1. The TRESTLE Anterior Cervical Plating System is an implant device used only to provide temporary internal fixation during the bone fusion process with the assistance of a bone graft. A successful result may not be achieved in every instance of use with this device. 2. Without solid bone fusion, this device cannot be expected to support the cervical spine indefinitely and may fail due to bone-metal interface or bone failure. 3. Based on the fatigue testing results, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, compliance of the patient, and other patient conditions which may have an impact on the performance and results of this system. 4. This product is a single use device. Under no circumstances should it be reused. While the device may appear to be undamaged, it may have small defects or internal stress patterns, as a result of the prior implantation or removal that could lead to fatigue failure. Additionally, please note that the removed implant has not been designed or validated so as to allow for decontamination of microorganisms. Reuse of this product could lead to cross-infection and/or material degradation as a result of the decontamination process. The company accepts no responsibility for products which have been reused. 5. Potential risks identified with the use of this device, which may require additional surgery, include device component fracture, loss of fixation, non-union, fracture of the vertebrae, and necrosis of bone, neurological injury and vascular or visceral injury. 6. Patients who smoke should be advised of the consequences of the fact that an increased incidence of non-union has been reported with patients who smoke. 7. Spinal surgery is not recommended for patients with alcohol abuse, morbid obesity, poor bone and muscle quality and/or nerve paralysis. 8. The implants and instruments are provided non-sterile and must be cleaned and sterilized before use. Device components should be sterilized using one of the noted validated sterilization cycle parameters. 9. This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine. 10. The TRESTLE Anterior Cervical Plating System has not been evaluated for safety and compatibility in the MR environment. The TRESTLE Anterior Cervical Plating System has not been tested for heating or migration in the MR environment INDICATIONS: The TRESTLE Anterior Cervical Plating System is intended for: 1. Use in the anterior cervical spine (C2-C7). 2. Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion. CONTRAINDICATIONS: The TRESTLE Anterior Cervical Plating System is contraindicated for: 1. Patients with osteopenia, osteoporosis, bone absorption or rapid joint disease. 2. Patients with infection in or adjacent to the spine or spinal structures, fever, leukocytosis. 3. Patients with probable titanium and/or Titanium alloy intolerance. 4. Patients with deficient soft tissue at the wound site or inadequate bone stock or quality. 5. Patients with morbid obesity or gross distorted anatomy due to congenital abnormalities. 6. Pregnant patients or patients with mental illness or other medical conditions which would prohibit beneficial surgical outcome. 7. Patients resistant to following post-operative restrictions on movement. 8. Use with components from other systems. 9. Use with bone cement. 10. Reuse or multiple uses. POSSIBLE ADVERSE EFFECTS: The following complications and adverse reactions have been shown to occur with the use of similar spinal instrumentation. These effects and any other known by the surgeon should be discussed with the patient preoperatively. 1. Loss of desired spinal curvature, spinal correction and/or a gain or loss in height. 2. Initial or delayed loosening, disassembly, bending, dislocation and/or breakage of device components. 3. Bone graft fracture, vertebral body fracture or discontinued growth of fused bone at, above and/or below the surgery level 4. Non-union or pseudoarthrosis. 5. In the case of insufficient soft tissue at and around the wound site to cover devices, skin impingement and possible protrusion through the skin may occur. 6. Physiological reaction to implant devices due to foreign body intolerance including inflammation, local tissue reaction, and possible tumor formation. 7. Neurological disorder including paralysis, appearance of radiculopathy and/or abnormal pain development. 8. Displacement of a screw due to incorrect positioning or implant size. 9. Hemorrhaging. U.S. Patents Pending 10. Infection. 11. Revision surgery. 12. Death. Emergo Europe Molenstaat 15 2513 BH The Hague The Netherlands Tel: (31) (0) 70 345-8570 15
Corporate Headquarters 5818 El Camino Real Carlsbad, California 92008 Customer Service Toll Free: 800.922.1356 Local: 760.431.9286 Fax: 800.431.1624 For more information, visit alphatecspine.com or contact Customer Service at 800 922 1356 or 760 431 9286 www.alphatecspine.com 5818 El Camino Real, Carlsbad, CA 92008 TRESTLE and the Alphatec Spine logo are registered trademarks of Alphatec Spine, Inc. 2010 Alphatec Spine, Inc. All rights reserved. LIT-83106J 2012/08/24