BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 3002488 · Received March 13, 2013

    Report

    Report Number
    1723170-2013-00184
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE PROVIDED.

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION. DEVICE MANUFACTURING DATE, PRIOR TO 2007, BUT IS UNKNOWN AT THIS TIME. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICE FINDS THE HEAD OF THE ALIGNMENT SCREW IS SLIGHTLY ROUNDED BUT THE HEX HEAD SPINE DRIVER TOOL FITS WITH SOME PLAY. FUNCTIONALLY TESTED THE CLAMP ON SOME PLASTIC, USING AN OPEN SPINE DRIVER AND WAS ABLE TO FULLY TIGHTEN THE CLAMP. ALSO WAS ABLE TO LOOSEN THE CLAMP WITH THE SAME DRIVER. MECHANICAL MALFUNCTION AND WEAR DIRECTLY CAUSED THIS EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A DAMAGED OPEN SPINE CLAMP THE TOP OF THE SCREW IS WORN OUT. NO PATIENT WAS PRESENT AT THE TIME THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104943 OPEN SPINE CLAMP, TITANIUM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 399869

    Patients

    Seq Age Sex Outcome Treatment
    1