BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 2040344 · Received February 15, 2011

    Report

    Report Number
    1723170-2011-00656
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K50438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO NOT PROVIDED AS NO PT WAS INVOLVED IN THIS CONCERN. DEVICE MFR DATES NOT AVAILABLE AT THE TIME OF THIS REPORT. PART INVESTIGATION ON BOTH SPINE CLAMPS CONFIRMED REPORTED ISSUE. THE ADJUSTMENT SCREW THREADS ARE STRIPPED THROUGH THE BARREL. THE CLAMP FACES MOVE FREELY. LOT NUMBERS FOR BOTH ARE LISTED IN THIS REPORT. ADD'L LOT # 138556.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THEY WERE NOT ABLE TO CLOSE THE CLAMP FACE ON TWO SPINE CLAMPS. THERE WAS NO PT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPEN SPINE CLAMP, TITANIUM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA 137629

    Patients

    Seq Age Sex Outcome Treatment
    1