BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IO FIX

    MDR report key: 8086906 · Received November 19, 2018

    Report

    Report Number
    3007289093-2018-00030
    Event Type
    Injury
    Date Received
    November 19, 2018
    Date of Event
    October 10, 2018
    Report Date
    November 19, 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

    IMPLANTS WERE REMOVED DUE TO PATIENT PAIN. THE JOINT DID FUSE. ITEMS REMOVED WERE 118-80625 AND 118-50045.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924848 IO FIX BONE SCREW HWC EXTREMITY MEDICAL, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention