No radiographs provided so the complaint cannot be confirmed.It is unknown if patient followed post-operative physical restrictions.Patient's bone quality is unknown.The length of time the implants were in use is unknown.It is unknown is a smoker.Due to a lack of reported information and no product failure reported the root cause cannot be determined though pseudoarthrosis is a known complication of surgical procedures and likely the result of patient related factors.No additional investigation can be completed.Labeling review: ".Potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: loss of fixation, nonunion or delayed union, decrease in bone density due to stress shielding." ".Patient education: 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." no device failure noted.
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