BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IO FIX SCREW AND WASHER SYSTEM

    MDR report key: 3187662 · Received June 20, 2013

    Report

    Report Number
    3007289093-2013-00002
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    October 31, 2012
    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
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT REQUIRED REVISION SURGERY TO REMOVE HARDWARE BECAUSE OF BROKEN IO FIX 4.0MM LAG SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281660 IO FIX SCREW AND WASHER SYSTEM SCREW, FIXATION, BONE HWC EXTREMITY MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention