It was reported that after an initial bunion surgery on (b)(6) 2021, all hardware was removed in a revision surgery on (b)(6) 2022 due to swelling.Additional information indicates the patient's bones were completely fused.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.Although a number of factors could have contributed to what was reported, the most likely cause cannot be determined.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any reported issues with placement of the device.The company will supplement this mdr as necessary and appropriate.
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