It was reported that a patient had a bunion correction surgery on (b)(6) 2020.During the surgery, the surgeon implanted ar-8717ds-0910 dynanite niti staple (lot: 926197317) to fix the osteotomy.The patient experienced infection and swelling post op.The surgeon treated the patient with rounds of antibiotics, before ultimately deciding to perform a hardware removal.The removal procedure took place on (b)(6) 2020.The revision surgery was performed by the same surgeon who performed the primary surgery, and took place at the same facility.There was no need for additional hardware as the fusion site had healed and there was no infection in the bone, just surrounding soft tissue which was sent for biopsy.The rep reported the bone was not affected during this procedure, and actually had a great fusion.Additional information received on 4/29/2020: it was reported that ar-8717ds-0910 (lot: 926197317) was the only arthrex product implanted during the primary surgery, and the only arthrex product removed during the revision surgery.The patient started experiencing a reaction/pain and discomfort on (b)(6) 2020.The patient was experiencing redness and swelling.Cultures were taken in office, and again during surgery.The patient tested positive for staphylococcus.There are no de-identified x-ray copies available.
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