BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IO FIX SCREW AND WASHER SYTEM

    MDR report key: 3189418 · Received June 20, 2013

    Report

    Report Number
    3007289093-2013-00008
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    April 6, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PRODUCT USED IN AN OFF-LABEL INDICATION FOR ELBOW FRACTURE REPAIR. PATIENT REQUIRED REVISION SURGERY TO REMOVE HARDWARE BECAUSE THE IO FIX 4.0MM LAG SCREW DISENGAGED FROM THE POST, POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280708 IO FIX SCREW AND WASHER SYTEM SCREW, FIXATION, BONE HWC EXTREMITY MEDICAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention