BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNLOADER ONE

    MDR report key: 1433103 · Received August 4, 2009

    Report

    Report Number
    3026585-2009-00003
    Event Type
    Injury
    Date Received
    August 4, 2009
    Date of Event
    July 7, 2009
    Report Date
    August 3, 2009
    Manufacturer
    OSSUR AMERICAS
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS BRACE WAS MANUFACTURED IN 2007, WHEN THE HINGE PLATES WERE STILL MADE OF PLASTIC. DUE TO REPEATED FLEXION/EXTENSION, THE ALUMINUM HINGE ARMS TORE THROUGH THE NYLATRON WASHER AND GROUND THEMSELVES INTO THE PLASTIC PLATE UNTIL THEY HAD REDUCED THEMSELVES TO HALF THEIR ORIGINAL THICKNESS, LEAVING A PERFECT ARC OF WEAR. ONE OF THE ARMS FINALLY FAILED ALL THE WAY THROUGH, EXPOSING A SHARP EDGE. THIS IS THE OLDEST UNLOADER ONE THAT WE HAVE RECEIVED BACK IN OUR HISTORY. A CORRECTIVE ACTION ON THIS PRODUCT, (ALUMINUM HINGE PLATE CORRECTIVE ACTION), IMPLEMENTED DECEMBER 2007 CORRECTED THIS ISSUE. WE NEED TO VERIFY CYCLIC FIELD EXPECTATIONS THRU ACCELERATED LAB TESTING. THE AGE OF THE RETURNED ITEM MAKES FOR AN IDEAL OPPORTUNITY TO VALIDATE THE IN-HOUSE TESTING IS SUFFICIENTLY REPRESENTATIVE/AGGRESSIVE AND MAY SHED LIGHT ON OUR RECOMMENDED SERVICE/REFURBISH SCHEDULE. THIS PRODUCT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    HINGE ARM OF BRACE SNAPPED JUST BELOW THE HINGE, MAKING A 1/2" CUT JUST BELOW THE PT'S KNEE ON THE MEDIAL SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNLOADER ONE IQI OSSUR AMERICAS B-115501710 1/2007

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other