KraniOS™ 1.6mm CRANIAL CLOSURE SYSTEM

The Integra Bone Fixation System includes titanium self- tapping and/or self- drilling screws and plates along with instruments for the fixation of bone fragments. The fixation screws are supplied in a variety of diameters and lengths designed to fit Integra’s various designs of fixation plates and burr hole covers. The Integra system includes reusable instruments such as screwdriver handles and blades.

Integra Bone Fixation System is intended for use in internal fixation of small bones affected by trauma, for reconstruction or arthrodesis. Burr hole cover plates are intended specifically to cover burr holes and to secure cranial bone flaps.

The Integra Bone Fixation System is contraindicated:

• In the presence of an active infection
• In patients with foreign body sensitivity where material sensitivity is suspected. Where material sensitivity is suspected, test should be performed to rule out this possibility prior to implantation.
• In conditions that limit the patient’s ability and/or willingness to cooperate and to follow instructions during the healing process.
  
• In patients with conditions such as limited blood supply, insufficient quantity or quality of bone and /or previous infections that may tend to retard healing and increase the possibility of infection and/or rejection of the implant.

• The Integra Bone Fixation System is intended to hold bone fragments during the healing process in areas free of muscular stresses or other weight bearing stresses.
• An implanted device should never be re-used. An explanted metal implant should never be re-implanted.
• Preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the implant, are important considerations in the successful use of the device.
• Advise the patient to report any unusual changes of the operated site to the surgeon. Closely monitor patients if a change in the fixation site has been detected. The surgeon should evaluate the possibility of subsequent clinical failure and discuss with the patient the need for any measures deemed necessary to aid healing.

• Contouring and bending fixation devices should be minimized, particularly avoiding sharp angles and repeat bending. Devices may be damaged or weakened due to repeated bending and should be discarded.
• Integra fixation plates, screws and instruments are designed to be used together. The use of products from other manufacturers with Integra implants can cause additional risks to the patient due to the possible contamination of the material and misalignment of the implant to the instruments.
• Deformed screw recesses can increase the risk of breakage and impair the accurate fit of the screw head to the plate.
• Careful handling and storage of the product is required. Scratching or damage to the component can significantly reduce the strength and fatigue resistance of the products.
• A cut fixation plate segment to be implanted may require deburring to prevent soft tissue injuries or irritations.
• Exactly align the screwdriver/screw head connection in the vertical directions to avoid mechanical damage to the implant or the screwdriver.
• When engaging the fixation screw, axial pressure of the screwdriver into the screw head must be adequately applied to ensure that the blade is fully inserted into the screw head.
• In the final phase of screw insertion, the underside of the screw head contacts either the bone or the screw head recess of the fixation plate, and a steep rise in resistance is clearly perceptible. Sensitive tightening of the screw must be exercised to reduce the risk of mechanical damage to the screw, screwdriver, or bony hole.

In many instances, adverse results may be clinically related rather than implant related.

• Osteoporosis, inhibited revascularization, bone resorption and poor bone formation can cause loosening, bending, cracking or fracturing of the device or premature loss of fixation with the bone, leading to nonunion.
• Delayed union, malunion or nonunion of the fracture site resulting from improper alignment.
• Increased fibrous tissue response around the fracture site due to unstable comminuted fractures.
• Early or late infection, both deep and/or superficial.
• Nerve damage may occur as a result of the surgical trauma.
• Metal sensitivity reactions in patients following surgical implant can occur, but have rarely been reported.