BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 3033635 · Received April 3, 2013

    Report

    Report Number
    1723170-2013-00243
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION. SUSPECT DEVICE WAS RETURNED TO MANUFACTURER FOR VISUAL EVALUATION: THE ADJUSTMENT SCREW HAS STRIPPED THREAD AND CANNOT BE ADJUSTED. THE PHYSICAL DAMAGE OF STRIPPED SCREW IS FOUND TO BE DIRECTLY RELATED TO THE ALLEGED MALFUNCTION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A BROKEN OPEN SPINE CLAMP. THIS EVENT WAS REPORTED OUTSIDE THE OPERATING ROOM, NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137042 OPEN SPINE CLAMP, TITANIUM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 120301

    Patients

    Seq Age Sex Outcome Treatment
    1