BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX

    MDR report key: 3232587 · Received July 18, 2013

    Report

    Report Number
    1030489-2013-03057
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 17, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL REVIEW AND OPTICAL OBSERVATION NOTED THE ONE OF THE SCISSOR JAWS AND ATTACHMENT PINS ARE MISSING, AND THE ATTACHMENT PIN HOLE APPEARS TO BE SHOW DEFORMATION, CONSISTENT WITH OVERLOAD. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ¿MOUTH¿ OF THE INSTRUMENT IS LOCKED IN AN OPEN POSITION; THE SCREWS FELL OFF. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333688 METRX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA GZ11C039

    Patients

    Seq Age Sex Outcome Treatment
    1