It was reported that after an initial bunion surgery, all hardware was removed in a revision surgery on (b)(6) 2022 due to irritation.Upon removal, there were no deficiencies or malfunctions alleged/found with any tmc device and no other patient outcomes were reported as a result of this event.
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It was reported that after an initial bunion surgery, all hardware was removed in a revision surgery on (b)(6) 2022 due to irritation.Additional information indicates the patient's bones were fully fused.Upon removal, there were no deficiencies or malfunctions alleged/found with any tmc device and no other patient outcomes were reported as a result of this event.Device specific information was not available, therefore a review of device history records was not able to be performed.However, all non-conformances for possible kits utilized in surgery were reviewed and no nonconformances or issues during the manufacture or release of the products were identified to date that could have contributed to what was reported.The most likely cause of the reported event could not be determined as the device was not returned for evaluation.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any issues with placement of the device.The company will supplement this mdr as necessary and appropriate.
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