BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD TRIAD SKULL CLAMP

    MDR report key: 2111064 · Received May 23, 2011

    Report

    Report Number
    3004608878-2011-00073
    Event Type
    Other
    Date Received
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    INTEGRA CINCINNATI
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED INFO AND EVAL OF THE RETURNED PRODUCT, THE FINDINGS WERE AS FOLLOWS: THE SLIPPAGE COULD NOT BE DUPLICATED WHEN THE RETURNED UNIT WAS PUT UNDER PRESSURE. THE 80 POUND TORQUE KNOB TESTED GOOD UNDER PRESSURE. THE RATCHET EXTENSION ARM HAD NO VISIBLE CRACKS. THE LOCK HAD ROTATIONAL MOVEMENT BUT THIS WOULD NOT HAVE CAUSED A SLIPPAGE. THE LARGE STARBURST TEETH SHOWED SOME WEAR BUT WAS STILL FUNCTIONAL. THERE WAS A LITTLE CRACK ON THE BOSS AND THE TRIAD WRENCH WAS MISSING; HOWEVER, THESE WOULD NOT HAVE CAUSED A SLIPPAGE. THE TRIAD ROCKER ARM PASSED THE GO NOGO GAGE. ALL OTHER COMPONENTS WERE 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

    THE SINGLE PIN SIDE DID NOT HOLD ENOUGH PRESSURE TO SUPPORT THE PT'S HEAD. AS A RESULT, THE PT RECEIVED A TWO INCH LACERATION ON THE FOREHEAD. ADD'L CLINICAL INFO HAS BEEN REQUESTED; HOWEVER, NO INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD TRIAD SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA CINCINNATI 047

    Patients

    Seq Age Sex Outcome Treatment
    1