BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IO FIX

    MDR report key: 8162087 · Received December 13, 2018

    Report

    Report Number
    3007289093-2018-00034
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    November 16, 2018
    Report Date
    December 13, 2018
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    HWC
    PMA / PMN Number
    K121349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A NON-UNION WAS REPORTED AFTER A NC AND TMT SURGICAL PROCEDURE. IO FIX DEVICES REMOVED AND PLATES WERE USED. NO REPORT OF DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998538 IO FIX BONE SCREW HWC EXTREMITY MEDICAL, LLC. 118-70615, 118-70630, 118-45128, 118-45132, 118-45136

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention