It was reported that after an initial bunion surgery on (b)(6) 2022, all hardware was removed on (b)(6) 2022 due to a post-op acquired infection.Additional information indicates the dressing applied post-op caused soft tissue disruption, necessitating removal of the hardware.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.The device history records for all devices intended to be implanted (sk14, sd20 and sd21) were reviewed and no issues were identified during the manufacture, sterilization or release of the devices that could have contributed to what was reported.Although a number of factors could have contributed to what was reported, based on feedback from the reporter, the infection is likely a result of the bandage applied post-operatively.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any issues with placement of the device.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, all hardware was removed on (b)(6) 2022 due to a post-op acquired infection.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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