BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEVICE #1 MAYFIELD SKULL CLAMP

    MDR report key: 5137570 · Received July 29, 2004

    Report

    Report Number
    3004608878-2004-00005
    Event Type
    Other
    Date Received
    July 29, 2004
    Date of Event
    June 24, 2004
    Report Date
    July 27, 2004
    Manufacturer
    SCHAERER MAYFIELD USA, INC.
    Product Code
    HBL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR MDR FILING PURPOSES PLEASE REFER TO INTEGRA LIFE CORPORATION INITIAL REGISTRATION OF DEVICE ESTABLISHMENT # (B)(4). THE SUSPECT DEVICE WAS RETURNED TO INTEGRA LIFESCIENCES CORPORATION ON (B)(6) 2004 AND EVALUATED. THE FOLLOWING IS A DOCUMENTED REPORT OF THE FINDINGS: DEVICE EVALUATION: THE 80 POUND TORQUE KNOB TESTED GOOD ON PRESSURES OF 20, 40, 60, AND 80 POUNDS. THE SWIVEL BASE HAD LITTLE TO NO MOVEMENT IN THE LOCKED POSITION AND HAD A POSITIVE LOCK. THE DEVICE IN QUESTION WAS FUNCTIONALLY TESTED UNDER PRESSURE AND WHEN PROPERLY POSITIONED, ADJUSTED, AND LOCKED, INTEGRA LIFESCIENCE CORPORATION WAS NOT ABLE TO DUPLICATE A CONDITION THAT WOULD CAUSE THE DEVICE TO SLIP WHILE UNDER PRESSURE. THE DEVICE PERFORMED PROPERLY. THE LARGE STARBURST NEEDED HELI COILS; THE THREADS WERE STARTING TO WEAR. ALTHOUGH THIS CONDITION WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THE ALLEGED "LOOSENED" CONDITION, THE PARTS WERE REPLACED. CONCLUSION: BASED ON THE NATURE OF THE PROBLEM, AND INTEGRA LIFESCIENCES EVALUATION RESULTS, NO DIRECT CONCLUSION COULD BE DETERMINED AS TO HOW OR WHY THE DEVICE ALLEGEDLY LOOSENED DESPITE 60 POUNDS OF PRESSURE APPLIED. CORRECTIVE ACTION: NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. HOWEVER, AS AN AID TO THE NEURO-SURGERY STAFF AT DOMINICAN HOSPITAL, INTEGRA LIFESCIENCES WILL SEND A COPY OF THE CD "MAYFIELD PROPER SKULL CLAMP POSITIONING". THE STAFF SHOULD FIND THIS HELPFUL.

    Description of Event or Problem · 1

    THE PATIENT WAS IN PRONE POSITION. ON TURNING THE SKULL CLAMP, THE CLAMP LOOSENED DESPITE SIXTY POUNDS OF PRESSURE. THE PATIENT SUSTAINED A 2 CM SCALP LACERATION WHICH WAS REPAIRED BY STAPLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVICE #1 MAYFIELD SKULL CLAMP SKULL CLAMP HBL SCHAERER MAYFIELD USA, INC. 4-0 A1059 997

    Patients

    Seq Age Sex Outcome Treatment
    1 Other