BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IO FIX

    MDR report key: 3596472 · Received January 22, 2014

    Report

    Report Number
    3007289093-2014-00005
    Event Type
    Injury
    Date Received
    January 22, 2014
    Report Date
    November 22, 2013
    Manufacturer
    EXTREMITY MEDICAL LLC
    Product Code
    HWC
    PMA / PMN Number
    K121349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVISION SURGERY PERFORMED USING IO FIX CONSTRUCT.

    Description of Event or Problem · 1

    IMPLANT CONSTRUCT WAS REVISED DUE TO PT NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53687 IO FIX SCREW, FIXATION, BONE HWC EXTREMITY MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention