BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1063015 · Received June 19, 2008

    Report

    Report Number
    1030489-2008-00281
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 27, 2008
    Report Date
    May 27, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. VISUAL EXAMINATION CONFIRMED THAT THE TIP WAS BROKEN OFF NEAR THE SPRING TAB STARTING POINT. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE CROSSLINK DRIVER WAS BROKEN OFF DURING USE IN SURGERY. NO PATIENT 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 BM06G006

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK