PAC PLATE A N T E R I O R C E RV I CA L P L AT E SYST E M S U R G I C A L T E C H N I Q U E

Transcription

1 PAC PLATE A N T E R I O R C E RV I CA L P L AT E SYST E M S U R G I C A L T E C H N I Q U E

2 PAC PLATE ANTERIOR CERVICAL PLATE SYSTEM Table of Contents INTRODUCTION System Overview... 1 SURGICAL TECHNIQUE Step 1 Surgical Exposure... Step 2 Graft Placement... Step 3 Plate Insertion... Step 4 Screw Hole Preparation... Step 5 Screw Placement... Step 6 Screw Removal... Step 7 Extraction... Step 8 Closure PRODUCT INFORMATION Instrument List... Implant List INDICATIONS Indications, Warning, Precautions, Contraindications Contributing Surgeon Matthew Songer, MD, MBA Marquette, Michigan 2

3 SURGICAL TECHNIQUE SYSTEM OVERVIEW PLATE FEATURES STANDARD AND DYNAMIC PLATE DIMENSIONS Plate Type Length Width One Level 10-26mm (2mm increments) 16mm Two Level 29-44mm (3mm increments) 16mm Three Level 43-58mm (3mm increments) 16mm Three Level 58-66mm (4mm increments) 16mm Four Level 60-84mm (4mm increments) 16mm DYNAMIC CERVICAL PLATE 2.5mm max 1.25mm max SYSTEM OVERVIEW PLATE HEIGHT/SCREW ANGLE Height At Screw hole At Graft Window Standard 2.5mm 1.95mm 18 Dynamic 2.5mm 2.5mm 20 Screw Angle (Convergence) Fixed 2mm max SCREW FEATURES Screw thread design and convergence features maximize pullout resistance Unique self-retaining plate/screw design reduces chances of screw back-out Color coded screws offer clear screw type identification SCREW SPECIFICATIONS Major Dimension: 4mm Minor Dimension: 2.67mm Thread Pitch: 1.6mm SELF-TAPPING SELF-DRILLING SCREW ANGLES Alignment Range of Angulation Cephalad/Caudal +/- 10 Medial/Lateral +/- 5 SCREW LENGTHS Screw Type Length Self-Tapping Screw 10-20mm Self-Drilling Screw 12-16mm Rescue Screw 12-16mm NOTE: Screw lengths are available in 2mm increments. SCREW DIAMETERS Fixed Diameters Self-Tapping Screw 4.0mm Self-Drilling Screw 4.0mm Variable Diameters Self-Tapping Screw 4.0mm Self-Drilling Screw 4.0mm Self-Tapping (Rescue) Screw 4.5mm 1

4 PAC PLATE ANTERIOR CERVICAL PLATE SYSTEM STEP 1 SURGICAL EXPOSURE SURGICAL EXPOSURE Perform the appropriate surgical exposure. Verify the affected level using radiographic assessment. Anterior osteophytes are typically removed with hand-held cutting instruments and/or powered high-speed burrs, where applicable, to provide optimal plate surface contact onto the anterior vertebral body. STEP 2 GRAFT PLACEMENT A discectomy is performed and the endplates are prepared. After discectomy and endplate preparation, insert the appropriate graft material. STEP 3 PLATE INSERTION To establish the location of the plate s most superior screw hole, notch the superior vertebral body with the Bone Awl (Figure 1). Figure 1 To determine the appropriate plate length, hold the Caliper by the handle, rotating the end knob counterclockwise so that the ball tips extend outward (Figure 2). Place one of the caliper ball tips into the proximal hole. Extend the opposing caliper ball tip to where the distal screw hole will be located (Figure 3). Figure 2 NOTE: The caliper is a spring-loaded memory instrument that returns the ball tips to the plate length that was established in the wound site. Figure 3 2

5 SURGICAL TECHNIQUE STEP 3 - PLATE INSERTION (CONTINUED) Place the caliper ball tips into the plate screw holes of the corresponding plate to verify the plate is the correct length (Figure 4). An alternative method of measuring the plate length is to place the caliper ball tips on each end of the plate. PLATE INSERTION NOTE: If overall plate length is the desired method of measurement, the same procedure is used with the calipers. Figure 4 If the plate requires additional contouring, use the Plate Bender. Place the plate carefully into the Plate Bender (Figure 5). IMPORTANT: Ensure that the Plate Bender s contact points are properly aligned, so that the plate is contoured over the graft window areas. Do not contour the plate over the screw holes as it may cause damage to the locking springs. Figure 5 CAUTION: Excessive contouring of the titanium plates can weaken the mechanical integrity of the device. The PAC Plate should not be contoured repeatedly, excessively, or in a kyphotic direction. Once the Plate Bender has been used to alter the contour of the plate, do not bend in the reverse direction, as this may introduce micro fractures within the titanium plate that can compromise its strength. If reverse plate bending or excessive bending has occurred, the bent plate must be discarded. Please contact Pioneer Surgical Technology at (888) with any questions in regard to contouring the plate prior to surgery. 3

6 PAC PLATE ANTERIOR CERVICAL PLATE SYSTEM STEP 4 SCREW HOLE PREPARATION SCREW HOLE PREPARATION Attach the selected plate to the Plate Holder and position upon the anterior surface of the prepared bone (Figure 6). The plate may be temporarily affixed to the vertebral bodies using the temporary holding pins (Figure 7). NOTE: The temporary holding pins must be replaced with implants. Figure 6 Surgical Tip 1 When using a dynamic plate (slotted holes), the potential for settling and/or movement under compressive loads may occur. Place the cephalad screws in the lower 1/3 of the vertebral body (Figure 8). Figure 7 Place the caudal screws in the upper 1/3 of the of the vertebral body. This ensures the upper and lower edges of the plate will not impinge upon the unaffected disc spaces adjacent to the plate if settling occurs. 1/3 NOTE: This guideline is recommended when using either variable or fixed screws. 1/3 NOTE: Specific to the dynamic plate, in order to allow for the maximum amount of subsidence, prepare the screw holes at the furthest position away from the fixed holes. For example, for the cephalad screw holes, prepare the screw holes in the most cephalad position within the slots. Figure 8 4

7 SURGICAL TECHNIQUE STEP 4 - SCREW HOLE PREPARATION (CONTINUED) Select the appropriate drill guide, i.e., Standard or Dynamic (See the PAC Plate Drill Guide Overview, MKT-020, for detailed information). Hold the drill guide securely against the plate when using a drill, tap, and/or driver (Figure 9). NOTE: The Standard and Dynamic drill guides, contained within the core set of instruments, allow you to drill, tap, and place a screw through the guide. WARNING: Please be sure to properly orient the drill guide handle, otherwise the tabs that extend below the distal tip of the drill guide could damage the locking springs (Figures 10A and 10B). Once it is fully seated within the screw hole, do not attempt to rotate the handle to another position. This rotation could cause the tabs to permanently displace the locking spring. Figure 9 Position the slots, between the distal tips, so they are parallel with the springs. Figure 10A SCREW HOLE PREPARATION IMPORTANT: When using a variable angle screw, do not exceed the allowable 10º of cephalad or caudal angluation. Angulation in excess of this may result in the screw head not fully seating under the spring. ONCE SEATED DO NOT ROTATE Figure 10B 5

8 PAC PLATE ANTERIOR CERVICAL PLATE SYSTEM SCREW HOLE PREPARATION STEP 4 - SCREW HOLE PREPARATION (CONTINUED) Surgical Tip 2 Two types of bone awl options are offered: 1) A Bone Awl (Figure 11), fixed handle or modular, designed to be used with drill guides or 2) the Self-Guided Awl (Figure 12). The Self-Guided Awl is used independently of the drill guides. The tip of this awl is placed in the center of the plate hole (Figure 13). When the outer sleeve advances toward the plate, it centers the awl tip within the plate hole, piercing the cortex of the vertebral body. Figure 11 Figure 12 Surgical Tip 3 Drill guides are designed to maintain a single entry point for the drills, taps, and screws. NOTE: Insert the drill bit or awl through the drill guide and advance it until the drill and/or awl bottoms out on the guide. If desired, place the tap through the drill guide and advance it until the shoulder makes contact with the guide. Figure 13 6

9 SURGICAL TECHNIQUE STEP 5 SCREW PLACEMENT Select the desired screw length and style (self-drilling or self-tapping). Insert the hex tip of the Driver into the head of the screw (Figure 14). Advance the hex portion of the Driver tip into the matching female hex socket in the screw head until the Driver bottoms out. Figure 14 SCREW PLACEMENT Next, slide the outer sleeve down until it makes contact with the screw. Rotate the sleeve clockwise until it stops (Figure 15). NOTE: It is important that the driver and screw shaft are aligned, otherwise, the threaded outer sleeve of the driver will not engage the threads inside the screw head. Figure 15 Place the screw through the drill guide until the tip makes contact with the anterior cortex. Turn the Driver clockwise, noting the etched lines on the Driver shaft (Figure 16). When the first etched line disappears through the drill guide, the screw head is making contact with the locking mechanism. When the second, thinner line disappears, the screw head is through the locking mechanism (Figure 17). An audible click may be heard when the screw head passes through the locking mechanism. Figure 16 Figure 17 7

10 PAC PLATE ANTERIOR CERVICAL PLATE SYSTEM STEP 5 - SCREW PLACEMENT (CONTINUED) SCREW PLACEMENT If desired, stop turning the Driver and postpone final advancement until all screws are placed. To remove the Driver, rotate the outer sleeve counterclockwise one to two turns and slide the outer sleeve toward the handle, withdrawing the Driver from the screw and drill guide. IMPORTANT: It is recommended that a small amount of axial force toward the handle of the driver be used when turning the outer sleeve counterclockwise. This provides tactile feedback that the outer sleeve has disengaged from the screw head. After the remaining screws are inserted, a three-finger technique can help verify that screws are securely tightened. Screws can be fully seated through the drill guide if desired. STEP 6 SCREW REMOVAL If a screw needs to be removed, the Driver (Figure 18) and the Screw Extractor Sleeve (Figure 19) should be used. Figure 18 Place the Driver through the Screw Extractor Sleeve. Advance the hex end of the Driver into the screw until it seats. Slide the outer sleeve of the Driver down until it makes contact with the screw. Figure 19 Rotate the outer sleeve of the driver clockwise until it stops advancing. IMPORTANT: Confirm the tips of the Screw Extractor Sleeve and the etched marks are pointing medial/lateral for the fixed holes and cephalad/caudal for the dynamic slots (Figure 20). Figure 20 8

11 SURGICAL TECHNIQUE STEP 7 EXTRACTION Rotate the locking sleeve of the Screw Extractor 90 while exerting firm downward pressure (Figure 21). The tips will push the springs out, allowing the screw head to pass through the retaining spring. Once the head clears the locking mechanism, release downward pressure while unscrewing. EXTRACTION If a rescue screw is required, select a variable self-tapping 4.5mm screw of the same length. A longer screw can be used to increase bone purchase, if there is sufficient room remaining in the vertebral body. Insert the replacement screw as described in Step 5. Figure 21 STEP 8 CLOSURE After the plate and screws are positioned in their desired location, a postoperative radiographic assessment should be taken to confirm final implant position. Wound closure is then performed. 9

12 PAC PLATE ANTERIOR CERVICAL PLATE SYSTEM INSTRUMENT LIST INSTRUMENTATION PRIMARY CASE Part Number Description 20-BONEAWL Cervical Bone Awl, 12mm 20-BONEAWLMOD Cervical Bone Awl, Modular, 12mm 20-CALIPER Caliper, Plate Sizing 20-CASE Cervical Case 20-DRILLFH Cervical Drill, Fixed, 12mm 20-DRILLMOD Cervical Drill, Modular, 12mm 20-DRIVER Cervical Driver 20-MODHANDLE Cervical Modular Handle 20- HOLDER Cervical Plate Holder 20-DYNDRGUIDE Dynamic Drill Guide 20-STDDRGUIDE Standard Drill Guide 20-GUIDEDAWL Self-Guided Awl 20-PIN Cervical Pin,Temporary, Plate Holding 20-PLTBENDER Cervical Plate Bender 20-TAPFH Cervical Tap, Fixed, 12mm 20-TAPMOD Cervical Tap, Modular, 12mm 20-XTRACTOR Cervical Screw Extractor Sleeve 20-MODDRILL10 Cervical Drill, Modular, 10mm 20-MODDRILL14 Cervical Drill, Modular, 14mm 20-MODAWL10 Cervical Awl, Modular, 10mm 20-MODAWL14 Cervical Awl, Modular, 14mm DRILL GUIDE CASE* Part Number Description 20-GUIDECASE Case, Drill Guides, PACP 20-FAGUIDEDYN Rongeur Style Drill Guide, Dynamic Hole 20-FAGUIDESTD Rongeur Style Drill Guide, Standard Hole 20-FDDGUID-0 Fixed Dynamic Drill Guide, 0º Cephalad 20-FDDGUID-90 Fixed Dynamic Drill Guide, 90º Cephalad 20-FSDGUID-0 Fixed Standard Drill Guide, 0º Cephalad 20-FSDGUID-90 Fixed Standard Drill Guide, 90º Cephalad 20-VDDGUID-0 Variable Dynamic Drill Guide, 0º Cephalad 20-VDDGUID-90 Variable Dynamic Drill Guide, 90º Cephalad 20-VSDGUID-0 Variable Standard Drill Guide, 0º Cephalad 20-VSDGUID-90 Variable Standard Drill Guide, 90º Cephalad 20-FDDBGUIDE Fixed Dynamic Double Barrel Drill Guide 20-FSDBGUIDE Fixed Standard Double Barrel Drill Guide *Optional: Must be ordered from Customer Service. 10

13 SURGICAL TECHNIQUE IMPLANT LIST ONE LEVEL STANDARD PLATES Part Number Description Overall Length S PAC Plate, Standard 1 Level 10mm S PAC Plate, Standard 1 Level 12mm S PAC Plate, Standard 1 Level 14mm S PAC Plate, Standard 1 Level 16mm S PAC Plate, Standard 1 Level 18mm S PAC Plate, Standard 1 Level 20mm S PAC Plate, Standard 1 Level 22mm S PAC Plate, Standard 1 Level 24mm S PAC Plate, Standard 1 Level 26mm ONE LEVEL DYNAMIC PLATES Part Number Description Overall Length D PAC Plate, Dynamic 1 Level 10mm D PAC Plate, Dynamic 1 Level 12mm D PAC Plate, Dynamic 1 Level 14mm D PAC Plate, Dynamic 1 Level 16mm D PAC Plate, Dynamic 1 Level 18mm D PAC Plate, Dynamic 1 Level 20mm D PAC Plate, Dynamic 1 Level 22mm D PAC Plate, Dynamic 1 Level 24mm D PAC Plate, Dynamic 1 Level 26mm IMPLANTS TWO LEVEL STANDARD PLATES Part Number Description Overall Length S PAC Plate, Standard 2 Level 29mm S PAC Plate, Standard 2 Level 32mm S PAC Plate, Standard 2 Level 35mm S PAC Plate, Standard 2 Level 38mm S PAC Plate, Standard 2 Level 41mm S PAC Plate, Standard 2 Level 44mm TWO LEVEL DYNAMIC PLATES Part Number Description Overall Length D PAC Plate, Dynamic 2 Level 29mm D PAC Plate, Dynamic 2 Level 32mm D PAC Plate, Dynamic 2 Level 35mm D PAC Plate, Dynamic 2 Level 38mm D PAC Plate, Dynamic 2 Level 41mm D PAC Plate, Dynamic 2 Level 44mm THREE LEVEL STANDARD PLATES Part Number Description Overall Length S PAC Plate, Standard 3 Level 43mm S PAC Plate, Standard 3 Level 46mm S PAC Plate, Standard 3 Level 49mm S PAC Plate, Standard 3 Level 52mm S PAC Plate, Standard 3 Level 55mm S PAC Plate, Standard 3 Level 58mm S PAC Plate, Standard 3 Level 62mm S PAC Plate, Standard 3 Level 66mm THREE LEVEL DYNAMIC PLATES Part Number Description Overall Length D PAC Plate, Dynamic 3 Level 43mm D PAC Plate, Dynamic 3 Level 46mm D PAC Plate, Dynamic 3 Level 49mm D PAC Plate, Dynamic 3 Level 52mm D PAC Plate, Dynamic 3 Level 55mm D PAC Plate, Dynamic 3 Level 58mm D PAC Plate, Dynamic 3 Level 62mm D PAC Plate, Dynamic 3 Level 66mm FOUR LEVEL STANDARD PLATES Part Number Description Overall Length S PAC Plate, Standard 4 Level 60mm S PAC Plate, Standard 4 Level 64mm S PAC Plate, Standard 4 Level 68mm S PAC Plate, Standard 4 Level 72mm S PAC Plate, Standard 4 Level 76mm S PAC Plate, Standard 4 Level 80mm S PAC Plate, Standard 4 Level 84mm FOUR LEVEL DYNAMIC PLATES Part Number Description Overall Length D PAC Plate, Dynamic 4 Level 60mm D PAC Plate, Dynamic 4 Level 64mm D PAC Plate, Dynamic 4 Level 68mm D PAC Plate, Dynamic 4 Level 72mm D PAC Plate, Dynamic 4 Level 76mm D PAC Plate, Dynamic 4 Level 80mm D PAC Plate, Dynamic 4 Level 84mm 11

14 PAC PLATE ANTERIOR CERVICAL PLATE SYSTEM IMPLANT LIST (CONTINUED) IMPLANTS FIXED SELF-DRILLING SCREWS Part Number Description Diameter Length FSD-12 PAC Screw, Fixed Self-Drilling 4.0mm 12mm FSD-14 PAC Screw, Fixed Self-Drilling 4.0mm 14mm FSD-16 PAC Screw, Fixed Self-Drilling 4.0mm 16mm FIXED SELF-TAPPING SCREWS Part Number Description Diameter Length FST-10* PAC Screw, Fixed Self-Tapping 4.0mm 10mm FST-12* PAC Screw, Fixed Self-Tapping 4.0mm 12mm FST-14* PAC Screw, Fixed Self-Tapping 4.0mm 14mm FST-16* PAC Screw, Fixed Self-Tapping 4.0mm 16mm FST-18* PAC Screw, Fixed Self-Tapping 4.0mm 18mm FST-20* PAC Screw, Fixed Self-Tapping 4.0mm 20mm VARIABLE SELF-DRILLING SCREWS Part Number Description Diameter Length VSD-12 PAC Screw, Variable Self-Drilling 4.0mm 12mm VSD-14 PAC Screw, Variable Self-Drilling 4.0mm 14mm VSD-16 PAC Screw, Variable Self-Drilling 4.0mm 16mm VARIABLE SELF-TAPPING SCREWS Part Number Description Diameter Length VST-10* PAC Screw, Variable Self-Tapping 4.0mm 10mm VST-12 PAC Screw, Variable Self-Tapping 4.0mm 12mm VST-14 PAC Screw, Variable Self-Tapping 4.0mm 14mm VST-16 PAC Screw, Variable Self-Tapping 4.0mm 16mm VST-18 PAC Screw, Variable Self-Tapping 4.0mm 18mm VST-20* PAC Screw, Variable Self-Tapping 4.0mm 20mm VARIABLE SELF-TAPPING SCREWS (RESCUE) Part Number Description Diameter Length VST-12 PAC Screw, Variable Self-Tapping, Rescue 4.5mm 12mm VST-14 PAC Screw, Variable Self-Tapping, Rescue 4.5mm 14mm VST-16 PAC Screw, Variable Self-Tapping, Rescue 4.5mm 16mm * Optional: Must be ordered from Customer Service. 12

15 SURGICAL TECHNIQUE INDICATIONS The PAC Plate (Pioneer Anterior Cervical Plate) System is intended for anterior cervical fixation as an adjunct to cervical fusion for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and alordosis), tumor, pseudoarthrosis, and failed previous fusion. INDICATIONS WARNINGS This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. PRECAUTIONS Only experienced spinal surgeons should perform the implantation of anterior cervical spinal systems with specific training in the use of this spinal system. This is a technically demanding procedure presenting a risk of serious injury to the patient. Preoperative planning and patient anatomy should be considered when selecting cervical screw diameter and length. While proper selection can help minimize risks, the size, shape, bone quality, stock, and differentiation of anatomical structures of human bones present limitations on the size, shape, and strength of implants. Metallic internal fixation devices cannot withstand activity levels equal to those placed on normal healthy bone. No implant can be expected to indefinitely withstand the unsupported stress of full weight bearing. No implant and screw system can withstand the forces of sudden dynamic loads such as falls or other accidents. Implants can break when subjected to the increased loading associated with delayed union or non-union. Internal fixation appliances are load-sharing devices, which are used to obtain an alignment until normal healing occurs. If healing is delayed or does not occur, the implant may eventually break due to metal fatigue. The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant. Notches, scratches or bending of the implant during the course of surgery may also contribute to early failure. Patients should be fully informed of the risks of implant failure. Mixing metals can cause corrosion. There are many forms of corrosion damage and several of these occur on metals surgically implanted in humans. General or uniform corrosion is present on all implanted metals and alloys. The rate of corrosive attack on metal implant devices is usually very low due to the presence of passive surface films. Dissimilar metals in contact, such as titanium and stainless steel, accelerates the corrosion process of stainless steel and a more rapid attack occurs. The presence of corrosion compounds released into the body system will also increase. Internal fixation devices, such as plates, rods, hooks, wires, etc. which come into contact with other metal objects, must be made from like or compatible metals. Surgical implants must never be reused. An explanted metal implant should never be re-implanted. Even though the device appears undamaged, it may have small defects and internal stress patterns which may lead to early breakage. Correct handling of the implant is extremely important. Contouring of the metal implants should only be done with proper equipment. The operating surgeon should avoid any notching, scratching or reverse bending of the devices when contouring. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant. Bending of screws will significantly decrease fatigue life and may cause failure. No implant and screw system can withstand the forces of sudden dynamic loads such as falls or other accidents. See product insert for complete labeling limitations related to this device. 13

16 2011 Pioneer Surgical Technology. All rights reserved. The trade name Pioneer Surgical as used herein and elsewhere refers to the legal entity Pioneer Surgical Technology, Inc. Pioneer Surgical owns the following trademarks: Pioneer, Moving Forward Together, and PAC Plate. The following trademarks are registered in the U.S.: Pioneer and PAC Plate. Authorized EC Representative: RSQR Ltd. Room 402 Ludgate House Fleet Street London EC4A 2AB Pioneer Surgical Technology BV Voorveste 7, 3992 DC Houten The Netherlands Tel / Fax info@pioneersurgical.eu CoC Utrecht Pioneer Surgical Technology 375 River Park Circle Marquette, MI (800) MKT-212-B/114755