BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD TRIAD SKULL CLAMP

    MDR report key: 2093964 · Received April 25, 2011

    Report

    Report Number
    3004608878-2011-00051
    Event Type
    Other
    Date Received
    April 25, 2011
    Date of Event
    March 25, 2011
    Manufacturer
    INTEGRA, CINCINNATI
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED INFORMATION AND EVALUATION OF THE RETURNED PRODUCTS, THE FINDINGS WERE AS FOLLOWS: THE CUSTOMER RETURNED 6 UNITS FOR REPAIR AND EVALUATION TO INTEGRA NOT KNOWING WHICH ONE WAS INVOLVED IN THIS INCIDENT. AFTER THE EVALUATION OF ALL OF THE 6 UNITS RECEIVED, IT HAD ALL TESTED WITHIN SPECIFICATIONS, AND THEREFORE, THE INCIDENT WAS NOT DUE TO THE MANUFACTURING OR DESIGN OF THE UNITS. THE INVESTIGATION FINDINGS OF THE 6 RETURNED UNITS WERE AS FOLLOWS: MAYFIELD TRIAD SKULL CLAMP (PRODUCT ID A1108 WITH LOT CODE 077): THE RECEIVED UNIT OPERATED NORMALLY DURING FUNCTIONAL TESTING. THE 80 POUND TORQUE KNOB TESTED GOOD UNDER PRESSURE. THE RATCHET EXTENSION ARM HAD NO VISIBLE CRACKS. THE LOCK HAD ROTATIONAL AND LATERAL MOVEMENT HOWEVER, THIS WOULD NOT HAVE CAUSED THE SLIPPAGE. THE LARGE STARBURST TEETH SHOWED SOME WEAR BUT WERE STILL FUNCTIONAL. THE TRIAD ROCKER ARM PASSED THE GO NOGO GAGE. ALL OTHER COMPONENTS WERE FUNCTIONAL. MAYFIELD TRIAD SKULL CLAMP (PRODUCT ID A1108 WITH LOT CODE 087): THE RECEIVED UNIT OPERATED NORMALLY DURING FUNCTIONAL TESTING. THE 80 POUND TORQUE KNOB TESTED GOOD UNDER PRESSURE. THE RATCHET EXTENSION ARM HAD NO VISIBLE CRACKS. THE LOCK HAD ROTATIONAL AND LATERAL MOVEMENT. THE LARGE STARBURST TEETH SHOWED SOME WEAR BUT WERE STILL FUNCTIONAL. THE TRIAD ROCKER ARM PASSED THE GO NOGO GAGE. THE TRIAD WRENCH WAS MISSING. THESE WOULD NOT HAVE CAUSED THE SLIPPAGE. ALL OTHER COMPONENTS WERE FUNCTIONAL. ULTRA BASE UNIT (PRODUCT ID 40A2101 WITH LOT CODE 041): ALL COMPONENTS WERE FUNCTIONAL AND THE REPORTED INCIDENT OF SLIPPAGE COULD NOT BE CONFIRMED OR DUPLICATED. MAYFIELD BASE UNIT (PRODUCT ID 40A1001 WITH LOT CODE 014) THE 6 INCH TRANSITION TEETH WERE WORN AND NEEDED TO BE REPLACED HOWEVER, THIS WOULD NOT HAVE CAUSED THE SLIPPAGE. THE ADJUSTMENT WRENCH WAS BROKEN, THE SHOCK CUSHION AND 1/4 PLASTIC PIN WERE WORN, AND THE LEFT BRACKET WOULD NOT SLIDE. HOWEVER, THESE WOULD NOT HAVE CAUSED THE SLIPPAGE. ALL OTHER COMPONENTS WERE FUNCTIONAL. MAYFIELD SWIVEL ADAPTOR (PRODUCT ID 40A1018 WITH LOT CODE 101): THE SWIVEL SLEEVE TEETH WERE A LITTLE WORN BUT WAS STILL FUNCTIONAL. THIS WOULD NOT HAVE CAUSED THE UNIT TO SLIP. ALL OTHER COMPONENTS WERE FUNCTIONAL. MAYFIELD SWIVEL ADAPTOR (PRODUCT ID 40A1018 WITH LOT CODE 104): THE SWIVEL SLEEVE TEETH WERE A LITTLE WORN BUT WERE STILL FUNCTIONAL. THIS WOULD NOT HAVE CAUSED THE UNIT TO SLIP. 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

    ON (B)(6) 2011, A (B)(6) PATIENT UNDERWENT A SUBOCCIPITAL CRANIOTOMY FOR A BRAIN MASS. THE PATIENT WAS IN A PRONE POSITION AND WAS NOT REPOSITIONED. NO STEREOTAXY DEVICE WAS USED. MAYFIELD INTEGRA DISPOSABLE SKULL PINS WITH LOT NUMBER 1104050 WERE USED. THE NATURE OF THE MALFUNCTION WAS REPORTED AS THE "LOCK SIDE WAS LOCKED BUT ROTATED". THE LENGTH OF TIME IN USE BEFORE THE EVENT OCCURRED WAS 10 MINUTES. THE PATIENT HAD A FIVE INCH LACERATION ON THE LEFT SIDE OF THE HEAD WHICH REQUIRED SUTURES. THE PATIENT WAS REPORTED AS STABLE. THE ENTIRE UNIT WAS REPLACED AFTER THE SLIPPAGE WITH NEW PINS. THE PINS WERE NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD TRIAD SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA, CINCINNATI 077 OR 087

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR