BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 3162073 · Received June 11, 2013

    Report

    Report Number
    1723170-2013-00424
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 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

    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. REPLACEMENT DEVICE SENT (B)(4) 2013. SUSPECT OPEN SPINE CLAMP HAS NOT YET BEEN RETURNED TO MANUFACTURER FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, DURING A SPINE PROCEDURE, THE SURGEON WAS TIGHTENING THE SPINOUS PROCESS CLAMP AND OVER-TIGHTENED IT TO THE POINT IT BROKE AND WOULD NO LONGER OPEN OR CLOSE PROPERLY. A SMALL CLAMP WAS USED TO PROCEED WITH THE SURGERY. 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
    263117 OPEN SPINE CLAMP, TITANIUM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR