It was reported that after an initial bunion surgery on (b)(6) 2022, the hardware was removed in a revision surgery on (b)(6) 2023 due to irritation.Additional information indicates the patient's bones were completely 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.No devices were returned for evaluation.The device history records were reviewed and no nonconformances or issues during the manufacture or release of the devices were identified 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 reported issues with placement of the device or healing of the surgical site.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) 2022, the hardware was removed in a revision surgery on (b)(6) 2023 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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