International sales manager, (b)(6) forwarded an email received from distributor affmed.Affmed reported in early (b)(6) 2021 a single rib was plated for a patient for non-union and pain control with a 50mm u+ plate and 6mm screws.There were no complications during the case.In late d (b)(6) 2021, the patient presented at the surgeon with pain again and stated, "it feels like something is lose".X-rays were taken in (b)(6)showing that there is rib necrosis, and the rib "has just about disappeared around the plate".The patient was going to be brought in the operating room within the next week or so to complete rib resection and removal of the plate and histology of remaining rib bone.Follow up attempts have been made to obtain further details regarding the event and product information to no avail.
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