483
Musculoskeletal Transplant Foundation, Inc.FDA 483 - Musculoskeletal Transplant Foundation, Inc. - November 17, 2021
Record Details
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.
- Inspection Date
- November 17, 2021
- Product Type
- Device
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ID · 73b462ac-9e95-467c-8ec9-56739edc9c4a