BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMCP

    MDR report key: 11703651 · Received April 21, 2021

    Report

    Report Number
    3007289093-2021-00004
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 29, 2021
    Report Date
    April 21, 2021
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    HWC
    PMA / PMN Number
    K121417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN AN XMCP CASE, THE FIRST X-POST USED ALLOWED THE HEAD OF THE LAG SCREW TO PASS THROUGH. THE X-POST WAS EXCHANGED FOR OTHER ONE, OF THE SAME SIZE, AND IT WAS PLACED FINE. FINAL RESULT WAS GOOD AND THE JOINT COMPRESSED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596763 XMCP BONE SCREW HWC EXTREMITY MEDICAL, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1