It was reported that after an initial bunion surgery on (b)(6) 2022, two plates and eight screws were removed in a revision surgery on (b)(6) 2022 due to mid-foot discomfort.Additional information indicates the patient's bones were fully fused.The surgeon suspects thin tissue contributed to the patient's discomfort.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 not returned to the manufacturer for evaluation.The device history records were reviewed and no issues were identified during the manufacture and release of the devices 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.However, it is possible the patient's thin tissue contributed to what was reported.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any 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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