BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1083820 · Received July 25, 2008

    Report

    Report Number
    1030489-2008-00389
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Report Date
    August 8, 2006
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO MEDTRONIC FOR EVALUATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE T25 DRIVER WAS BROKEN DURING USE IN SURGERY. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT DRIVER LXH MEDTRONIC SOFAMOR DANEK NA BM05C013

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK