BEUDAMED
    FDA Adverse Event Other Summary report: N

    IO FIX SCREW AND WASHER SYSTEM

    MDR report key: 2805554 · Received October 17, 2012

    Report

    Report Number
    3007289093-2012-00011
    Event Type
    Other
    Date Received
    October 17, 2012
    Date of Event
    September 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    EXTREMITY MEDICAL, LLC
    Product Code
    HWC
    PMA / PMN Number
    K121349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    PATIENT REQUIRED REVISION SURGERY TO REMOVE HARDWARE BECAUSE OF NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IO FIX SCREW AND WASHER SYSTEM SCREW, FIXATION, BONE HWC EXTREMITY MEDICAL, LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention