BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 3202482 · Received July 2, 2013

    Report

    Report Number
    1723170-2013-00495
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA ISSUED. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT OPEN SPINE CLAMP FOUND PHYSICAL DAMAGE TO THE HEAD OF THE ADJUSTMENT SCREW. THE HEAD HAS BEEN ROUNDED. THE ADJUSTABLE JAW IS BENT TO ON SIDE AND NO LONGER ALIGNS WITH THE LOWER JAW. THE REPORTED ISSUE COULD BE DUPLICATED. PHYSICAL DAMAGE/DEFORMATION DIRECTLY CAUSED THE EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, A LONG OPEN SPINE CLAMP WAS STRIPPED. THE SURGEON USED A THORACIC CLAMP, INSTEAD OF THE OPEN SPINE CLAMP, TO CONTINUE. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302661 OPEN SPINE CLAMP, TITANIUM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 081215

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR