BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XMCP

    MDR report key: 10476253 · Received September 1, 2020

    Report

    Report Number
    3007289093-2020-00018
    Event Type
    Injury
    Date Received
    September 1, 2020
    Date of Event
    July 31, 2020
    Report Date
    August 31, 2020
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    HWC
    PMA / PMN Number
    K121417
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT PAIN AND NON UNION ABOUT 1 YEAR AFTER INITIAL SURGERY. XMCP IMPLANTS WERE REMOVED AND THE SURGEON USED ILLIAC CREST BONE GRAFT TO FILL VOID, STABILIZED WITH K WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941471 XMCP BONE SCREW HWC EXTREMITY MEDICAL, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR