It was reported that after an initial bunion surgery on (b)(6) 2020, two plates and eight screws were removed on (b)(6) 2021 due to a suspected infection.Upon hardware removal, no failure or deficiency was found with any tmc hardware and the patient's bones were fully fused/healed.Additional information indicates culture tests came back negative and the surgeon believes what the patient had were only visible signs of infection superficial to the incision site which were unrelated to the hardware.The device history records for kit sk14 were reviewed and no issues were identified during the manufacture, sterilization or release of the kit that could have contributed to what was reported.Although a number of factors could have contributed to what was reported, the most likely cause cannot be determined.The surgeon ultimately determined what the patient experienced was a superficial infection of the skin only, which was likely acquired post-operatively based on the available information.The company will supplement this mdr as necessary and appropriate.
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It was reported that after an initial bunion surgery on (b)(6) 2020, two plates and eight screws were removed on (b)(6) 2021 due to a suspected infection.Upon hardware removal, no failure or deficiency was found with any tmc hardware and the patient's bones were fully fused/healed.
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