BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 2214081 · Received July 19, 2011

    Report

    Report Number
    3004608878-2011-00095
    Event Type
    Other
    Date Received
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    INTEGRA, CINCINNATI
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA LIFESCIENCES ENGINEERS HAVE COMPLETED A THROUGH INVESTIGATION OF THE RETURNED MAYFIELD MODIFIED SKULL CLAMP AND HAVE PROVIDED THE FOLLOWING; THE RETURNED UNIT WAS PUT UNDER PRESSURE AND THE ENGINEERS WERE UNABLE TO DUPLICATE THE SLIPPAGE. THE 80 POUND TORQUE KNOB TESTED GOOD UNDER PRESSURE, THE RATCHET EXTENSION ARM HAD NO VISIBLE CRACKS; THE LOCK HAD ROTATIONAL AND LATERAL MOVEMENT, BUT THIS WOULD NOT CAUSE A SLIPPAGE. THE LARGE STARBURST TEETH SHOWED SOME WEAR, BUT WERE STILL FUNCTIONAL. THE UNIT ALSO NEEDED HELICOILS, BUT THIS WOULD NOT HAVE CAUSED A SLIPPAGE. THE ROCKER ARM PASSES GO NOGO GAGE; ALL OTHER COMPONENTS WERE FUNCTIONAL. IN SUMMARY THE RETURNED UNIT PASSED ALL FUNCTIONAL TESTING - REQUIREMENTS THEREFORE THE ROOT CAUSE IS NOT DUE TO THE DESIGN OR MANUFACTURE OF THE DEVICE. 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 MODIFIED SKULL CLAMP WAS INVOLVED IN A SLIPPAGE DURING A PROCEDURE. THE PATIENT EXPERIENCED A LACERATION AS A RESULT. ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1