BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IO FIX

    MDR report key: 7944473 · Received October 8, 2018

    Report

    Report Number
    3007289093-2018-00014
    Event Type
    Injury
    Date Received
    October 8, 2018
    Date of Event
    August 23, 2018
    Report Date
    October 8, 2018
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    HWC
    PMA / PMN Number
    K121349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786342 IO FIX SCREW, FIXATION, BONE HWC EXTREMITY MEDICAL, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention