On (b)(6) 2022, it was reported by a sales representative via phone that 4 out of 9 ar-3638 fibertaks pulled out of implantation site.The surgeon used 3 pushlocks to complete the case without further issues.This was discovered during a revision bankart procedure on (b)(6) 2022.Surgeon stated that the original implanted sutures had torn and were not holding the labrum down, which lead to the bankart procedure to be performed.The sales representative does not know when or where the original procedure took place.Surgeon who performed this revision procedure is not the same surgeon who performed the original procedure.It could not be confirmed either if the implants were arthrex devices, however, nothing got explanted, only the sutures were cut.The original anchors were implanted deep in the bone and could not be removed.No further details were given regarding the original procedure.
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