It was reported that after an initial bunion surgery on (b)(6) 2022, the medial plate was removed in a revision surgery on (b)(6) 2022 due to irritation.Additional information indicates the patient's bones were fully 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 device 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 or healing of the surgical site.The company will supplement this mdr as necessary and appropriate.
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