BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOFAB CUSTOM DEVICE

    MDR report key: 24656167 · Received March 20, 2026

    Report

    Report Number
    3009582362-2026-00001
    Event Type
    Injury
    Date Received
    March 20, 2026
    Report Date
    March 20, 2026
    Manufacturer
    OXFORD PERFORMANCE MATERIALS, INC.
    Product Code
    SAI
    PMA / PMN Number
    520(B) EXMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WHO RECEIVED CUSTOM DEVICE OFC0810-B DEVELOPED A POST-OPERATIVE INFECTION AND THE DEVICE WAS REMOVED. A REPLACEMENT DEVICE WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711408 OSTEOFAB CUSTOM DEVICE CUSTOM ORTHOPEDIC IMPLANT SAI OXFORD PERFORMANCE MATERIALS, INC. OFC0810-B 218463

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention| O| H