FDA 483 - Musculoskeletal Transplant Foundation, Inc. - November 17, 2021

Musculoskeletal Transplant Foundation, Inc. in Edison, NJ, was inspected regarding its manufacturing of Acellular Dermis Matrix (ADM) implantable devices. The inspection revealed a significant failure in post-market surveillance, as the firm did not submit required Medical Device Reports (MDRs) for over 150 complaints of serious adverse events associated with its breast augmentation and reconstructive devices. This indicates a serious lapse in reporting adverse events to the FDA.