BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1881224 · Received October 6, 2010

    Report

    Report Number
    1030489-2010-01303
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUF
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS CANNOT BE PERFORMED WITHOUT ADD'L DEVICE INFO. WITHOUT RETURN OF THE DEVICE OR ASSOCIATED RECORDS IT IS NOT POSSIBLE TO ASCERTAIN A CAUSE FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS BROKEN DURING USE. NO PT COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK