BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD TRIAD SKULL CLAMP

    MDR report key: 2220060 · Received August 9, 2011

    Report

    Report Number
    3004608878-2011-00109
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    INTEGRA, CINCINNATI
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA LIFESCIENCES HAVE COMPLETED A THOROUGH EVAL OF THE MAYFIELD TRIAD SKULL CLAMP (THE PINS COULD NOT BE REMOVED FROM THE PTS HEAD) AND HAVE PROVIDED THE FOLLOWING; THIS UNIT HAS PASSED ALL FUNCTIONAL TESTING REQUIREMENTS. THE 80# TORQUE KNOB TESTED GOOD UNDER PRESSURE; THE RATCHET EXTENSION ARM HAS NO VISIBLE CRACKS; THE LOCK HAS ROTATIONAL MOVEMENT. THE LARGE STARBURST TEETH SHOW SOME WEAR BUT STILL FUNCTIONAL. THE TRIAD ROCKER ARM PASSES GO NOGO GAGE. ALL OTHER COMPONENTS ARE FUNCTIONAL. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    A MAYFIELD TRIAD SKULL CLAMP WAS INVOLVED IN AN INCIDENT AND WAS DESCRIBED AS FOLLOWS; THE PINS COULD NOT BE REMOVED FROM THE PTS HEAD. THERE WAS NO INJURY AS A RESULT OF THIS EVENT, BUT HAS THE POTENTIAL TO CAUSE INJURY. ADD'L CLINICAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD TRIAD SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA, CINCINNATI

    Patients

    Seq Age Sex Outcome Treatment
    1