BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 3234029 · Received July 18, 2013

    Report

    Report Number
    1723170-2013-00529
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA ISSUED. REPLACEMENT OPEN SPINE CLAMP SHIPPED TO SITE (B)(4) 2013. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICE FINDS THAT AS REPORTED, THE ADJUSTMENT SCREW THREADS ARE STRIPPED IN THE MIDDLE OF THE TRAVEL RESTRICTING MOVEMENT. THERE IS ALSO MUCH DEBRIS IN THE THREADS THAT MAY HAVE CONTRIBUTED TO THE STRIPPED THREADS. OTHERWISE, THE CLAMP WAS FOUND TO BE IN GOOD CONDITION. THIS MECHANICAL FAILURE DIRECTLY CAUSED THE EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A STRIPPED SPINE SCREW ON AN OPEN SPINE CLAMP. THIS WAS DISCOVERED WHEN ATTEMPTING TO ATTACH THE FRAME TO THE PATIENT DURING A SURGERY. THE SURGEON USED A SECOND CLAMP TO CONTINUE. THE SURGEON COMPLETED THE PROCEDURE 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
    335116 OPEN SPINE CLAMP, TITANIUM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 120514

    Patients

    Seq Age Sex Outcome Treatment
    1