BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 3252800 · Received July 29, 2013

    Report

    Report Number
    1723170-2013-00554
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 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

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. DEVICE LOT NUMBER, OR SERIAL NUMBER, NOT AVAILABLE AT TIME OF THIS REPORT. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE AT THIS TIME. RMA ISSUED. SUSPECT OPEN SPINE CLAMP HAS NOT BEEN RETURNED TO MANUFACTURER FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 1

    SUSPECT DEVICE EVALUATED: THE ADJUSTMENT SCREW THREADS ARE WORN IN THE CENTER OF THE TRAVEL NOT ALLOWING THE CLAMP FACE TO MOVE. THE SCREW HEAD HAS TOOL MARKS ALL AROUND. OTHERWISE, THE CLAMP IS IN GOOD CONDITION. A NEW CLAMP WAS SENT TO THE SITE FOR ISSUE RESOLUTION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A STRIPPED OPEN SPINE CLAMP. THERE WAS NO PATIENT PRESENT WHEN THIS CONCERN WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353155 OPEN SPINE CLAMP, TITANIUM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 120514

    Patients

    Seq Age Sex Outcome Treatment
    1