OSTEOMED Logic Mandibular Distraction System

Description The OSTEOMED Logic Mandibular Distraction System is an intraoral bone distractor. It features various curved and straight bars activated with an activation wire (threaded wire) that has screw holes that are fixed to bone via 1.6mm or 2.0mm bone screws. The distractor is available in right and left versions. The activation wire is activated by a hex driver and is capable of distraction lengths of up to 25mm. Material The Distractor assembly is made from Titanium Alloy (ASTM-F-136) and Titanium (ASTM-F-67). The threaded guide wire is made from Nickel Titanium and Titanium Alloy (ASTM-F-136). The screws are made from Titanium Alloy (ASTM-F-136). The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or acetal copolymer plastic. Clinical Indications The OSTEOMED Logic Mandibular Distraction System is indicated for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia. The OSTEOMED Logic Mandibular Distraction System is intended for single patient use only. OsteoMed single use devices/instruments cannot be reused and/or reprocessed. The product has been labeled as single use only for patient safety. The design of the device and the intricacies of the surfaces may not facilitate cleaning and sterilization after contact with body tissues or fluids, so there is an increased risk of contamination if reused. This may lead to potential risks of cross infection/contamination associated with using inadequately cleaned and sterilized devices. For cutting instruments the cutting efficacy may be reduced requiring the surgeon to use increased force that might cause patient harm and/or increase the risk of thermal necrosis. Because these products have not been validated for multiple uses, OsteoMed cannot guarantee the safety and effectiveness of the device if it is used on more than one patient. Contraindications Use of the OSTEOMED Logic Mandibular Distraction System is contraindicated in cases of active or suspected infection, in patients previously sensitized to nickel, titanium, or silicone; in patients with upper airway obstruction with certain metabolic diseases, or patients who are immune compromised. It is further contraindicated in patients exhibiting disorders which would cause the patient to ignore the limitations of distraction osteogenesis. The OSTEOMED Logic Mandibular Distraction System is also contraindicated in those cases where there is an inadequate volume or quality of bone to place the distractor securely. Warnings 1. Plates, screws, wires, or other appliances of dissimilar metals should not be used together in or near the implant site. 2. Multiple bending may weaken the device and could result in implant fracture and failure. 3. Do not remove activation wire before the consolidation period has been completed. 4. Distractor must be fixated with a minimum of 2 screws on each arm of the moving plate and the stationary plate. 5. The activation wire must be turned in the direction of the arrow as indicated on the handle of the distraction tool. 6. Patient’s activities must be governed according to the limitations of the device. 7. Surgeon should limit patient to a soft diet for the duration of the distraction period. 8. Precautions should be taken to avoid damage to the inferior alveolar or facial nerves. 9. During distraction and consolidation period, the soft-tissue portal must remain clean. 10. Minimal MRI scattering is possible due to nickel present in the activation wire. 11. The silicone tubing is indicated for a maximum implant period of 29 days. 12. Excessive torque on the activation wire may cause the wire to break. 13. Failure to follow Planning instructions may contribute to patient harm. 14. Failure to follow Implantation instructions may cause patient harm or device damage. 15. Failure to follow Distraction instructions may cause patient harm or device damage. 16. Failure to follow Distractor removal instructions may cause patient harm. 17. The devices can break or be damaged due to excessive activity or trauma. This could lead to failure of the distractor and/or screws which could require additional surgery and device removal. 18. It is recommended to remove any fractured implants from patients during surgery. If unable to remove, notify patient/guardian. 19. Use of screws in high density bone may lead to implant fracture or failure upon insertion. 20. Use of excessive force during insertion of screws may lead to implant failure. MRI Status: The OSTEOMED Logic Mandibular Distraction System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for radio frequency (RF) heating, migration due to magnetically induced displacement, or image artifact in the MR environment. The safety of the implants in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. Precautions 1. The patient/guardian is to be warned that the device can break or loosen as a result of stress, excessive activity or inappropriate diet. 2. The patient/guardian is to be made aware of the surgical risks and possible adverse effects prior to surgery, and warned that failure to follow postoperative care instructions can cause failure of the implant and the treatment. 3. Surgeon should limit patient activity while device is implanted. 4. Surgeon should limit patient to a soft diet for the duration of the distraction period. 5. Precautions should be taken to avoid damage to the inferior alveolar nerve and tooth buds. 6. During distraction, the activation wire should be kept coaxial (aligned) with the distractor body. Maintaining Device Effectiveness 1. The surgeon should have specific training, experience, and thorough familiarity with the use of intraoral distraction products and techniques. 2. The surgeon must exercise reasonable judgment when deciding which plate and screw type to use for specific indications. 3. The OSTEOMED Logic Mandibular Distraction System is not intended to endure excessive abnormal functional stresses. 4. The OSTEOMED Logic Mandibular Distraction System is intended for temporary fixation once intended distraction is achieved and mandibular distraction osteogenesis occurs. 5. All OsteoMed implants and instrumentation may be required for each surgery. Failure to use dedicated, unique OsteoMed instruments for every step of the implantation technique may compromise the integrity of the implanted device, leading to premature device failure and subsequent patient injury. Failed devices may require re-operation and removal. 6. Carefully inspect the OsteoMed implants prior to use. Inspect the instruments before and after each procedure to assure they are in proper operating conditions. Instruments which are faulty, damaged, or suspect should not be used. They should be replaced or sent to OsteoMed for disposition and repair. 7. Care must be taken not to damage threads on the activation wire during implantation. 8. OsteoMed recommends the use of OsteoMed products in a sterile environment. 9. Drill using the appropriate pilot drill. Note: Speed and torque parameters must be in accordance to the power system instructions for use. Use irrigation when pilot drilling.