BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 2920515 · Received January 17, 2013

    Report

    Report Number
    1723170-2013-00033
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    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.MEDTRONIC REPRESENTATIVE AT THE SITE IDENTIFIED THE ISSUE WITH THE OPEN SPINE CLAMP ADJUSTMENT SCREW. THE SITE HAS NOT REQUESTED A REPLACEMENT OPEN SPINE CLAMP TO DATE; NO RMA WAS ISSUED. SUSPECT DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 1

    THE HEAD OF THE ALIGNMENT SCREW IS SLIGHTLY ROUNDED BUT SPINE DRIVE FITS WITH VERY LITTLE PLAY. THERE IS NO STRIPPED THREADS. FUNCTIONALLY TESTED THE CLAMP ON SOME PLASTIC, USING THE OPEN SPINE DRIVE AND WAS ABLE TO FULLY TIGHTEN THE CLAMP. ALSO WAS ABLE TO LOOSEN THE CLAMP WITH THE SAME DRIVER. THE CLAMP IS FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED AN ADJUSTMENT SCREW ON AN OPEN SPINE CLAMP THAT WAS STRIPPED AND WOULD NO LONGER TIGHTEN DOWN PROPERLY. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25634 OPEN SPINE CLAMP, TITANIUM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 100818

    Patients

    Seq Age Sex Outcome Treatment
    1