No device has been returned for evaluation at this time, a lateral radiograph was provided confirming the backed lock screw.The patient was not reported to have experienced any falls, post op physical activity levels could not be confirmed.Due to the lack of information provided a root cause could not be determined but a review of the reported information and similar reported events suggests possible insufficient final torque applied, rod interference related to insufficient reducing/normalization, implant selection and placement and/or excessive post operative activity as cause or contributors to the event.No lot number could be provided so a review of the manufacturing history could not be performed.No additional investigation can be completed at this time, should more information be received a follow-up report will be completed.Label review: ".Potential adverse events and complications - as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss of fixation." ".All lock screws should be final-tightened with the counter-torque and torque t-handle.Do not final-tighten through compression instruments (e.G.C/d rack and figure 8 compressor) in the set, as the rod may not be able to normalize to the tulip." ".Patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed." h3 other text : device not returned.
|