BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1914463 · Received November 23, 2010

    Report

    Report Number
    3004608878-2010-00134
    Event Type
    Other
    Date Received
    November 23, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 23, 2010
    Manufacturer
    INTEGRA, OHIO
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA LIFESCIENCES ENGINEERS HAVE COMPLETED A THOROUGH INVESTIGATION OF THE RETURNED MAYFIELD SKULL CLAMP AND HAVE PROVIDED THE RESULTANT FINDINGS AS FOLLOWS; THE RETURNED DEVICE PASSED ALL FUNCTIONAL AND PERFORMANCE TESTING AS RECEIVED. THE ROOT CAUSE IS NOT RELATED TO THE MANUFACTURE OR THE DESIGN 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 SKULL CLAMP (B)(4) WAS INVOLVED IN AN INCIDENT DURING A PROCEDURE AND WAS DESCRIBED AS FOLLOWS; A (B)(6) MALE WAS UNDERGOING A POSTERIOR CERVICAL FORAMINOTOMY. THE MAYFIELD SKULL CLAMP WAS PLACED ON THE PT AND HE WAS REPOSITIONED IN A PRONE POSITION WHEN THE UNIT SLIPPED CAUSING A LACERATION, APPROX ONE INCH IN LENGTH. THE LACERATION REQUIRED STAPLING. THERE WAS NO STEREOTAXY DEVICE BEING USED AT THE TIME OF THIS INCIDENT. DISPOSABLE SKULL PINS WERE BEING USED DURING THE PROCEDURE MODEL NUMBER, LOT NUMBER AND SIZE OF THE PINS WAS NOT PROVIDED. THE PINS WERE DISCARDED FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR