BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1021056 · Received March 28, 2008

    Report

    Report Number
    1030489-2008-00167
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 29, 2008
    Report Date
    February 29, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN RETURNED TO MEDTRONIC FOR EVAL. EVAL IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE T20 TORX DRIVER WAS BROKEN OFF UNDER TORSIONAL LOAD INSIDE THE SETSCREW OF THE AXIAL CONNECTOR. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN FRAGMENT. 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 BM07F005

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK