BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IO FIX SCREW AND WASHER SYSTEM

    MDR report key: 2806704 · Received October 23, 2012

    Report

    Report Number
    3007289093-2012-00014
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    April 19, 2011
    Report Date
    October 23, 2012
    Manufacturer
    EXTREMITY MEDICAL LLC
    Product Code
    HWC
    PMA / PMN Number
    K121349
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    INTENDED PROCEDURE WAS CHARCOT MIDFOOT RECONSTRUCTION. SURGEON BELIEVES THAT THE PT'S FOOT DORSIFLEXED DURING CASTING AND POSSIBLY CAUSED THE CONSTRUCT TO DISENGAGE.

    Description of Event or Problem · 1

    POST-OP PT F/U REVEALED THAT THE LAG SCREW HAD DISENGAGED FROM THE WASHER; CONSTRUCT LOOSENING.

    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