BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1083883 · Received July 25, 2008

    Report

    Report Number
    1030489-2008-00377
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    December 19, 2006
    Report Date
    December 19, 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 RETURNED TO MEDTRONIC FOR EVALUATION. VISUAL EXAMINATION CONFIRMED THE TIP OF THE INSTRUMENT IS BROKEN ON EACH SIDE. 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 CORONAL PLANE BENDER WAS BROKEN 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 CORONAL PLANE BENDER LXH MEDTRONIC SOFAMOR DANEK NA NM05M002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK