Integra. CONSTRUCT Ankle Fusion Plating System SURGICAL TECHNIQUE

Transcription

1 Integra CONSTRUCT Ankle Fusion Plating System SURGICAL TECHNIQUE

2 Table of Contents Introduction Indications...2 Contraindications...2 System Features and Benefits...2 Anterior Ankle Fusion Surgical Technique Primary Ankle Fusion Step 1: Incision & Preparation of Joint Surfaces... 3 Step 2: Plate Placement...4 Step 3: Insertion of Talus Screws...4 Step 4: Compression Using Tibial Screws... 5 Step 5: Closure...6 Lateral TTC Fusion Surgical Technique Step 1: Incision & Preparation of Joint Surfaces... 7 Step 2: Plate Selection... 7 Step 3: Targeting Guide Assembly... 7 Step 4: Insertion of the Calcaneal Screws...8 Step 5: Anterior Screw Insertion...9 Step 6: Proximal Screw Placement Step 7: Proximal Screw Placement Step 8: Closure Instrument Tray Ordering Information Essential Product Information... 14

3 Indications The CONSTRUCT Ankle Fusion Plate System is intended for the following: Arthrodesis of the ankle joint and tibia Fractures, osteotomies, fusions, and replantations of small bones in the foot and ankle. Contraindications Not indicated for fixation to the posterior elements of the cervical, thoracic, or lumbar spine. Screws are contraindicated in: active infection, conditions which tend to retard healing such as blood supply limitations, previous infections, insufficient quantity or quality of bone to permit stabilization of the fracture complex, conditions that restrict the patient s ability or willingness to follow postoperative instructions during the healing process and foreign body sensitivity. Cases with malignant primary or metastatic tumors which preclude adequate bone support or screw fixations, unless supplemental fixation or stabilization methods are utilized. Foreign body sensitivity where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implementations. These implants are intended as a guide to normal healing, and are NOT intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing. Delayed unions or non-unions in the presence of load bearing or weight bearing might eventually cause the implant to break due to metal fatigue. All metal surgical implants are subjected to repeated stress in use, which can result in metal fatigue. See package insert for full prescribing information.* System Features and Benefits Anatomic anterior and lateral locking plates in one set for surgical flexibility Reconstruction plate options for spanning and fixating grafts during revision cases Plate holes accommodate 4.5 & 6.5 mm locking and compression screws for rigid fixation Interfragment screw targeting guide attaches to lateral plate for ideal placement without interference of locking plate screws Anterior plate preserves the posterior hinge allowing even joint compression and stability Joint compression can be achieved through the plate for an ideal fusion site *ESSENTIAL PRODUCT USE INFORMATION: For additional important information pertaining to the use of this product, please see product package insert. This information was current at the time of printing, but may have been revised after that date. 2

4 Anterior Ankle Fusion Surgical Technique Primary Ankle Fusion As the manufacturer of this device, Integra LifeSciences Corporation does not practice medicine and does not recommend this or any other surgical technique for use on a specific patient. The surgeon who performs any procedure is responsible for determining and using the appropriate technique in each patient. Caution: Federal law restricts this device to sale by or on the order of a physician or practitioner. Step 1 Incision & Preparation of Joint Surfaces 1-1 A skin incision is made directly anterior to the ankle joint, bisecting the medial and lateral malleoli. Deepen the skin incision only to the subcutaneous layer, identifying and protecting the superficial peroneal nerve and its crossing branches where possible. 1-1 Identify the plane between the tibialis anterior and the EHL tendons. Incise the extensor retinaculum in this plane. Be aware that the neurovascular bundle lies between these structures proximal to the ankle joint. Retract the tibialis anterior tendon medially and divide the deeper soft tissues and ankle capsule directly to bone, just lateral to the bed of the tibialis anterior. A vascular leash of vessels is usually encountered anterior to the ankle joint proper, and electric cautary is usually necessary. Subperiostally dissect the soft tissues off the anterior distal tibia and talar neck until the medial and lateral malleoli are well visualized. Take care to place no undo tension on the skin or the soft tissues anterior to the ankle joint. Manual retraction is preferred, but deep self-retaining retractors (such as gelpy retractors) avoiding tension of the skin, may be acceptable. Using an osteotome or saggital saw, remove any anterior osteophytes, including the anterior malleolus until there is no anterior prominence. The roof of the distal tibial articular surface is then well visualized, and there is no overhang of the distal tibia, relative to the anterior cartilaginous surface of the talus. Also remove any osteophytes or bony prominences over the distal aspect of the talus just proximal to the talonavicular joint. Remove the cartilage and subchondral bone from the distal tibia and talar dome, taking care to preserve the posterior malleolus and posterior capsule. The cartilage may be removed from the posterior malleolus, but to maintain a posterior hinge, the bone and soft tissue should be preserved. Using an osteotome or reciprocating saw, the cartilaginous surfaces of the medial and lateral gutter are removed to ensure there are no restrictions to proper positioning. Take care not to violate the subtalar joint with the cuts. Using a small osteotome, feather both joint surfaces to ensure no subchondral surfaces remain. Pack the ankle joint firmly with the surgeon s bone graft of choice to ensure continuous contact with bone or bone graft between the fusion surfaces. 3

5 Step 2 Plate Placement 2-1 AFP-A07RT Right Anterior Ankle Fusion Plate, 7 Hole 2-1 AFP-A09RT AFP-A07LT AFP-A09LT Right Anterior Ankle Fusion Plate, 9 Hole Left Anterior Ankle Fusion Plate, 7 Hole Left Anterior Ankle Fusion Plate, 9 Hole Firmly dorsiflex the foot to a neutral position. Select and apply the proper plate to the anterior ankle. Check that the plate sits flush on the anterior tibia and talar neck, ensuring that there is not an anterior overhang onto the talonavicular joint. The PF Pin or K-wires may be applied to the tibia, taking care not to fix the plate to the anterior tibia at this time. PF Pin Step 3 Insertion of Talus Screws 3-1 Using the red sleeve on the double-sided Double Drill Guide and the 3.2 mm Drill Bit, drill the most proximal screw hole on 3-1 the talar limb. Take care not to violate the subtalar joint with the drill or the screw. Double Drill Guide and 3.2 mm Drill Bit 3-2 Use the Depth Gauge to select the appropriate 4.5 mm Compression Screw to compress the plate to the talar neck. At this time, check a lateral radiograph to ensure the plate is sitting appropriately to the talar neck, and the long axis of the ankle is parallel to the plate. If the plate appears appropriate, place the remaining two locking screws in the talus. 3-2 Rachet Driver 3-3 Screw the 4.5 mm Locking Drill Guide into the distal hole. Use the 3.2 mm Drill Bit and take care not to violate the subtalar joint mm Locking Drill Guide and 3.2 mm Drill Bit 4

6 3-4 Use the Depth Gauge to select the appropriate 4.5 mm Locking Screw. Insert the screw until fully seated and threaded into 3-4 the plate. 3-5 Repeat this process to fill the lateral talar body screw with a 6.5 mm Locking Screw, utilizing the 6.5 mm gold Locking Drill Guide and the 5.0 mm Drill Bit mm gold Locking Drill Guide & 5.0 mm Drill Bit 3-6 Once again, assure the screw is fully seated into the plate. 3-6 Step 4 Compression Using Tibial Screws 4-1 Properly align the foot in dorsiflexion/plantarflexion and 4-1 varus/valgus. Place the Compression Drill Guide in the more distal oblong hole. The 3.2 mm Drill Bit should be placed further Compression Drill Guide away from the fusion site, with the compression arrow & 3.2 mm Drill Bit oriented proximally. 5

7 4-2 Perform drilling and use the Depth Gauge to measure for the placement of a bicortical non-locking screw to further 4-2 compress the joint. Insert the screw until fully seated and joint compression is visualized. 4-3 Repeat this process in the proximal lateral oblong hole, remembering to loosen the first tibial screw placed prior to compression with the second screw. Use the Locking Drill Guide to drill for the final two locking screws For the use of a 4.5 mm Locking Screw, thread the 4.5 mm Locking Drill Guide into the screw hole. Attach the 3.2 mm Drill Bit to power and advance the drill through the guide until the appropriate depth is reached. Remove the Drill Guide and insert the Depth Gauge to determine the appropriate size screw. For the use of a 6.5 mm Locking Screw, thread the 6.5 mm Locking Drill Guide into the screw hole. Attach the 5.0 mm Drill Bit to power and advance the drill through the guide until the appropriate depth is reached. Remove the Drill Guide and use the Depth Gauge to determine the appropriate size screw. The plate is now fixated, and closure can be performed Step 5 Closure Closure should be performed in a layered fashion after hemostasis is achieved. Care should be taken to close the extenser retinaculum. 6

8 Lateral TTC Fusion Surgical Technique As the manufacturer of this device, Integra LifeSciences Corporation does not practice medicine and does not recommend this or any other surgical technique for use on a specific patient. The surgeon who performs any procedure is responsible for determining and using the appropriate technique in each patient. Caution: Federal law restricts this device to sale by or on the order of a physician or practitioner. Step 1 Incision & Preparation of Joint Surfaces 1-1 Using a surgical marker, outline the boundaries of the fibula. Place the appropriate lateral ankle fusion plate on the skin to estimate the exposure necessary for positioning. An extensile lateral approach is taken down to bone to the distal tip of the fibula, proceeding distally to create a calcaneal flap The peroneal tendons are usually sacrificed to decompress the area and allow for better soft tissue coverage. The fibula is osteotomized at an angle to prevent a prominent edge, just proximal to the most proximal portion of the plate. An osteotome is used to aid in removal of the fibula and to prepare a flat surface along the lateral TTC joints for the plate to sit flush. The TTC joints are prepared for arthrodesis per surgeon preference. The excised fibula can be used as bone graft. 1-2 Fibular Resection Step 2 Plate Selection Select the corresponding lateral fusion plate. The plate is anatomically pre-contoured to fit the anatomy of the TTC. Step 3 Targeting Guide Assembly Place the correlating Targeting Base over the proximal 2 mm diameter threaded hole with the sleeve positioned anteriorly. Thread the Targeting Base Knob (GTB ) through the guide and into the plate. Tip The targeting guide is properly placed when the proximal two tibial holes are completely covered by the guide and the distal two tibial holes are visualized. AFP-L09RT AFP-L09LT GTB GTB Right Lateral Ankle Fusion Plate, 9 Hole Left Lateral Ankle Fusion Plate, 9 Hole Guide Pin Targeting Base, Left (Red) Guide Pin Targeting Base, Right (Green) 7

9 3-1 The Targeting Guide can be used as a handle during plate placement. Place the plate onto the lateral surface so that the distal four holes align with the calcaneus, the single middle hole aligns with the talus, and the proximal four holes are aligned with the tibia. Temporary fixation is achieved by inserting the PF Pins through the distal two tibia plate holes for rotational stability during interfragmentary screw placement. 3-1 Targeting Guide & PF Pins Step 4 Insertion of the Calcaneal Screws 4-1 In order to maintain rotational stability and assure the interfragmentary screw does not impede on plate screws, fixating the distal portion of the plate is recommended prior to insertion of the interfragmentary anterior compression screw. The use of 4.5 mm or 6.5 mm locking and non-locking screws is surgeon preference and varies based upon patient anatomy and disease state. However, using a non-locking screw first is recommended to compress the plate to bone. 4-1 Double Drill Guide & 3.2 mm Drill Bit 4-2 For the use of non-locking 4.5 mm (shown) or 6.5 mm screws, use the 3.2 mm side of the Double Drill Guide. Place the guide into the screw hole for 15 of variability. Once the proper angle has been determined, insert the 3.2 mm Drill Bit through the guide until adequate depth is achieved. Remove Drill Guide and insert the Depth Gauge to determine the correct size screw. Insert the correlating non-locking screw using the TX-25 Torx Driver until the screw is seated. 4-2 TX-25 Torx Driver 4-3 Once the plate is compressed to the calcaneus, insertion of locking screws may be performed. For the use of a 6.5 mm Locking Screw (shown), thread the 6.5 mm Locking Drill Guide into the screw hole. Attach the 5.0 mm Drill Bit to power and advance the drill through the guide until the appropriate depth is reached mm Locking Drill Guide & 5.0 mm Drill Bit 4-4 Remove Drill Guide and use the Depth Gauge to determine the appropriate size screw. Select the correlating 6.5 mm Locking Screw and drive until the screw is fully seated into the plate using the TX-25 Torx Driver. Continue with the insertion of the remaining two calcaneal holes

10 Step 5 Anterior Screw Insertion 5-1 With the plate fixed to the calcaneus with screws and to the tibia with PF Pins, compression of the TTC joint may be achieved using a 6.5 mm Compression Screw. Slide the Guide Pin Targeting Sleeve into the Targeting Base slot and advance the thread until seated. Insert the 3.2 mm Long Drill Bit through the Guide Pin Targeting Sleeve until appropriate depth is achieved in the calcaneus, making a stab incision at the entry point of the drill, or by moving the skin flap over the anterior tibia. 5-1 Guide Pin Targeting Sleeve & 3.2 mm Long Drill Bit 5-2 Remove the Targeting Sleeve. Place the Countersink w/ao Quick Connect through the Targeting Base until countersink depth is achieved. Determine the appropriate size screw by inserting the Depth Gauge for Plate Screws into the drill hole. Advance the corresponding screw using the driver until the screw head is slightly proud of the anterior tibia. At this point, the PF Pins are loosened to allow for compression of the TTC joint. The screw is now seated and compression is achieved. Placement of the screw is confirmed with fluoroscopy. The targeting guide assembly is now removed and the PF Pins can be re-seated for stability. 5-2 Optional CAPTURE 7.0 mm High-Torque Cannulated Screw Placement Note CAPTURE High-Torque Cannulated Screws are provided in a separate instrument set. 5-3 After assembly of Targeting Base, insert a 3.2 mm Guide Pin from the CAPTURE 7.0 mm High-Torque System through the Guide Pin Targeting Sleeve until appropriate depth is achieved in the calcaneus, making a stab incision at the entry point of the Guide Pin, or by moving the skin flap over the anterior tibia. Remove the Targeting Sleeve. Place the cannulated Countersink/Depth Gauge over the Guide Pin and rotate back and forth until countersink depth is achieved. Determine the appropriate size screw based upon the Depth Gauge reading. Select the correlating screw and place it over the Guide Pin. Advance the screw using the driver until the screw head is slightly proud of the anterior tibia. At this point, the PF Pins are loosened to allow for compression of the TTC joint. The screw is now seated and compression is achieved. Placement of the screw is confirmed with fluoroscopy. The targeting guide assembly is now removed and the PF Pins can be re-seated for stability. 5-3 Optional Cannulated Countersink/Depth Gauge 9

11 Step 6 Proximal Screw Placement 6-1 The tibial holes may now be fixated using locking and non-locking screws. For the use of a 4.5 mm Locking Screw, thread the 4.5 mm Locking Drill Guide into the screw hole. Attach the 3.2 mm Drill Bit to power and advance the drill through the guide until the appropriate depth is reached. Remove the Drill Guide and insert the Depth Gauge to determine the appropriate size screw. Select the correlating 4.5 mm Locking Screw and drive until the screw is seated into the plate using the TX-25 Torx Driver. If using non-locking screws, bicortical fixation is recommended mm Locking Drill Guide & 3.2 mm Drill Bit 6-2 Proceed using the technique for locking and non-locking screws as necessary until the proximal four holes are utilized, removing the PF Pins as needed. 6-2 Step 7 Proximal Screw Placement 7-1 Thread the 6.5 mm Locking Drill Guide into the plate hole that aligns with the talus. Insert the 5.0 mm Drill Bit through the guide to the appropriate depth. Remove the Drill Guide and insert the screw Depth Gauge to determine the appropriate size screw. Remove the 6.5 mm Locking Screw from the caddy and insert using the TX-25 Torx Driver until the screw is seated into the plate The plate is now fixated and any soft tissue repairs may be performed. 7-2 Step 8 Closure Closure is performed per standard protocol. 10

12 CONSTRUCT Ankle Fusion Plating System Instrument Tray Drill Bits 2. Left Lateral Plate 3. Right Lateral Plate 4. Left Anterior Plates 5. Right Anterior Plates 6. Left Guide Pin Targeting Base 7. Targeting Base Knobs 8. Guide Pin Targeting Sleeves 9. Right Guide Pin Targeting Base 10. Double Drill Guide 11. Compression Drill Guide 12. Ratchet Driver Handle 13. Osteotome 14. Depth Gauge 15. TX 25 Driver Shaft 16. Large PF Pin 17. Locking Drill Guides 18. AO to Trinkle Adapter 19. Screw Holding Forceps 20. Countersink 21. Drill Bits mm Guide Pins mm Compression Screws mm Locking Screws mm Compression Screws mm Locking Screws 11

13 Plates 6.5 mm Screws Catalog Number Description Catalog Number Description AFP-L09RT AFP-L09LT AFP-A07RT AFP-A07LT AFP-A09RT AFP-A09LT 4.5 mm Screws Catalog Number PSS-4514CT PSS-4516CT PSS-4518CT PSS-4520CT PSS-4522CT PSS-4524CT PSS-4526CT PSS-4528CT PSS-4530CT PSS-4532CT PSS-4534CT PSS-4536CT PSS-4538CT PSS-4540CT PSS-4545CT PSS-4550CT PSS-4555CT PSS-4560CT PSS-4565CT PSS-4570CT PSS-4575CT PSS-4580CT PSS-4514LT PSS-4516LT PSS-4518LT PSS-4520LT PSS-4522LT PSS-4524LT PSS-4526LT PSS-4528LT PSS-4530LT PSS-4532LT PSS-4534LT PSS-4536LT PSS-4538LT PSS-4540LT PSS-4545LT PSS-4550LT PSS-4555LT PSS-4560LT PSS-4565LT PSS-4570LT PSS-4575LT PSS-4580LT Right Lateral Ankle Fusion Plate, 9 Hole Left Lateral Ankle Fusion Plate, 9 Hole Right Anterior Ankle Fusion Plate, 7 Hole Left Anterior Ankle Fusion Plate, 7 Hole Right Anterior Ankle Fusion Plate, 9 Hole Left Anterior Ankle Fusion Plate, 9 Hole Description 4.5mm Compression Screw, 14mm 4.5mm Compression Screw, 16mm 4.5mm Compression Screw, 18mm 4.5mm Compression Screw, 20mm 4.5mm Compression Screw, 22mm 4.5mm Compression Screw, 24mm 4.5mm Compression Screw, 26mm 4.5mm Compression Screw, 28mm 4.5mm Compression Screw, 30mm 4.5mm Compression Screw, 32mm 4.5mm Compression Screw, 34mm 4.5mm Compression Screw, 36mm 4.5mm Compression Screw, 38mm 4.5mm Compression Screw, 40mm 4.5mm Compression Screw, 45mm 4.5mm Compression Screw, 50mm 4.5mm Compression Screw, 55mm 4.5mm Compression Screw, 60mm 4.5mm Compression Screw, 65mm 4.5mm Compression Screw, 70mm 4.5mm Compression Screw, 75mm 4.5mm Compression Screw, 80mm 4.5mm Locking Screw, 14mm 4.5mm Locking Screw, 16mm 4.5mm Locking Screw, 18mm 4.5mm Locking Screw, 20mm 4.5mm Locking Screw, 22mm 4.5mm Locking Screw, 24mm 4.5mm Locking Screw, 26mm 4.5mm Locking Screw, 28mm 4.5mm Locking Screw, 30mm 4.5mm Locking Screw, 32mm 4.5mm Locking Screw, 34mm 4.5mm Locking Screw, 36mm 4.5mm Locking Screw, 38mm 4.5mm Locking Screw, 40mm 4.5mm Locking Screw, 45mm 4.5mm Locking Screw, 50mm 4.5mm Locking Screw, 55mm 4.5mm Locking Screw, 60mm 4.5mm Locking Screw, 65mm 4.5mm Locking Screw, 70mm 4.5mm Locking Screw, 75mm 4.5mm Locking Screw, 80mm PSS-6530CT PSS-6532CT PSS-6534CT PSS-6536CT PSS-6538CT PSS-6540CT PSS-6545CT PSS-6550CT PSS-6555CT PSS-6560CT PSS-6565CT PSS-6570CT PSS-6575CT PSS-6580CT PSS-6520LT PSS-6522LT PSS-6524LT PSS-6526LT PSS-6528LT PSS-6530LT PSS-6532LT PSS-6534LT PSS-6536LT PSS-6538LT PSS-6540LT PSS-6545LT PSS-6550LT PSS-6555LT PSS-6560LT PSS-6565LT PSS-6570LT PSS-6575LT PSS-6580LT 6.5mm Compression Screw, 30mm 6.5mm Compression Screw, 32mm 6.5mm Compression Screw, 34mm 6.5mm Compression Screw, 36mm 6.5mm Compression Screw, 38mm 6.5mm Compression Screw, 40mm 6.5mm Compression Screw, 45mm 6.5mm Compression Screw, 50mm 6.5mm Compression Screw, 55mm 6.5mm Compression Screw, 60mm 6.5mm Compression Screw, 65mm 6.5mm Compression Screw, 70mm 6.5mm Compression Screw, 75mm 6.5mm Compression Screw, 80mm 6.5mm Locking Screw, 20mm 6.5mm Locking Screw, 22mm 6.5mm Locking Screw, 24mm 6.5mm Locking Screw, 26mm 6.5mm Locking Screw, 28mm 6.5mm Locking Screw, 30mm 6.5mm Locking Screw, 32mm 6.5mm Locking Screw, 34mm 6.5mm Locking Screw, 36mm 6.5mm Locking Screw, 38mm 6.5mm Locking Screw, 40mm 6.5mm Locking Screw, 45mm 6.5mm Locking Screw, 50mm 6.5mm Locking Screw, 55mm 6.5mm Locking Screw, 60mm 6.5mm Locking Screw, 65mm 6.5mm Locking Screw, 70mm 6.5mm Locking Screw, 75mm 6.5mm Locking Screw, 80mm 12

14 Instruments Catalog Number LDG LDG DDG CDG PDG TSS FS-1006 gs gs CSK PFP GTB GTB GTB GTS gs Description 4.5mm Locking Drill Guide 6.5mm Locking Drill Guide 5.0mm/3.2 mm Double Drill Guide 3.2mm Compression Drill Guide Depth Gauge for Plate Screws TX 25 Driver Shaft w/quick Connect Ratchet Driver Handle AO Trinkle Adapter Screw Holding Forceps Countersink w/ao Quick Connect Large PF Pin w/ao Quick Connect Guide Pin Targeting Base, Left (Red) Guide Pin Targeting Base, Right (Green) Targeting Base Knob Guide Pin Targeting Sleeve 3/4 Wide Str. Smith Peterson Osteotome Anterior Ankle Fusion Locking Plate Disposables Catalog Number GDW DRL DRL DRL Description 2.0mm x 150mm Guide Pin 3.2mm Long Drill Bit 3.2mm Drill Bit 5.0mm Drill Bit Lateral TTC Fusion Locking Plate 13

15 Essential Product Information Warnings and Precautions No metallic surgical implant should be reused. Any metal implant, once used, should be discarded. Even though it appears undamaged, it may already have small defects and internal stress patterns which may lead to fatigue failure. Correct handling of implant is extremely important. Avoid contouring metallic implants whenever possible. If necessary, or allowed by design, the device should not be bent sharply, reverse bent, notched or scratched. All of these operations can produce defects in the surface finish and internal stress concentrations, which may become the focal point for eventual failure of the appliance. If metal plates or other metallic devices are to be used together with the Ankle Fusion Plates, all such devices should be manufactured from a metal that has a similar composition to avert possibility of galvanic corrosion or other metallic reactions. Correct selection of the implant is extremely important. The potential for success in fracture fixation is increased by the selection of the proper size, shape and design of the implants. The patient s anatomy and indication will determine the size of the Ankle Fusion Plate to be used. The size and shape of the human bones presents limiting restrictions on the size and strength of implants. Postoperative care is extremely important. The patient must be warned that noncompliance with postoperative instructions could lead to breakage of the implant requiring revision surgery to remove the device. The use of Ankle Fusion Plates provides the surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries. The implant are intended as a guide to normal healing and are NOT intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing. Delayed unions or nonunions in the presence of load bearing or weight bearing might eventually cause the implant to break due to metal fatigue. All metal surgical implants are subject to repeated stress in use which can result in metal fatigue Failure to immobilize a delayed union or nonunion of bone will result in excessive and repeated stresses which are transmitted by the body to any temporary internal fixation device prior to the healing of the fracture. Due to normal metal fatigue, these stresses can cause eventual bending or breakage of the device. Therefore, it is important that immobilization of the fracture site is maintained until firm bony union (confirmed by clinical and roentgenographic examination) is established. No partial weight bearing or nonweight bearing device can be expected to withstand the unsupported stresses of full weight bearing. Until firm bone union is achieved, the patient should employ adequate external support and restrict physical activities which would place stress upon the implant or allow movement at the fracture site and delay healing. Detailed written instructions on the use and limitations of the device should be given to the patient. If partial weight bearing is recommended or required prior to firm bony union, the patient must be warned that bending or breakage of the device are complications which may occur as a result of the weight bearing or muscle activity. An active patient or a debilitated or demented patient who cannot properly utilize weight support devices may be particularly at risk during postoperative rehabilitation. While the surgeon must make the final decision on implant removal, whenever possible and practical for the individual patient, fixation devices should be removed once their service as an aid to healing is accomplished, particularly in younger more active patients. The Ankle Fusion Plate System has not been evaluated for safety and compatibility in the MR environment. The Ankle Fusion Plate System has not been tested for heating or migration in the MR environment. 14

16 Integra CONSTRUCT Ankle Fusion Plating System For more information or to place an order, please contact: Integra n 311 Enterprise Drive, Plainsboro, NJ USA n outside USA n fax integralife.com CONSTRUCT, Integra and the Integra logo are registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries Integra LifeSciences Corporation. All rights reserved. Printed in USA. 3k