No product has been returned for evaluation as the device was left in-situ, x-ray films provided confirm the alleged event.Even though root cause cannot be confirmed, information received indicated a torque was not used at the time of event which may have contributed to alleged event.The patients post-op activity levels were unknown.".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)¿" ".All lock screws should be final-tightened with the counter-torque and torque t-handle." ".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." ".Post-operative warnings.During the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques.".
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On (b)(6) 2020, a patient underwent a posterior fixation procedure.During a routine post operative follow up appointment, radiographs were taken to assess hardware, and it was discovered that a lock screw had backed out.As per reporter, the patient is currently asymptomatic and at this time and there is no plans for revision.
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