BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 2200834 · Received August 11, 2011

    Report

    Report Number
    1030489-2011-01023
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    August 4, 2010
    Report Date
    April 22, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EXAMINATION OF THE DEVICE FOUND NO MATERIAL OR FUNCTIONAL DAMAGE. FUNCTIONAL TEST FOUND NO ISSUES WITH RESPECT TO ATTACHMENT OR RETENTION OF THE IMPLANT. INSTRUMENT FUNCTIONED AS INTENDED. COULD NOT DUPLICATE THE CUSTOMER CONCERN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT INSERTER WAS WORN SO IT WOULD NOT HOLD THE IMPLANT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING MA05K145

    Patients

    Seq Age Sex Outcome Treatment
    1