It was reported that after an initial bunion surgery, all tmc hardware was removed in a revision surgery on (b)(6) 2020 due to irritation.The device was not returned to the manufacturer for evaluation.Device specific lot information was not available; therefore, a review of device history records was not able to be performed.However, all non-conformances for sk12 and sk14 were reviewed and no non-conformances or issues during the manufacture or release of the product were identified to date that could have contributed to what was reported.Based on the available information, the cause of what was reported 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, all hardware was removed in a revision surgery on (b)(6) 2020 due to irritation.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.
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