BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IO FIX SCREW AND WASHER SYSTEM

    MDR report key: 3187694 · Received June 20, 2013

    Report

    Report Number
    3007289093-2013-00003
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    EXTREMITY MEDICAL, LLC
    Product Code
    HWC
    PMA / PMN Number
    K121349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTED BROKEN IO FIX LAG SCREW POST-OPERATIVELY. INVESTIGATION ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281119 IO FIX SCREW AND WASHER SYSTEM SCREW, FIXATION, BONE HWC EXTREMITY MEDICAL, LLC UNK, 113872

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention