BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD 2000 SKULL CLAMP

    MDR report key: 2802644 · Received October 19, 2012

    Report

    Report Number
    3004608878-2012-00187
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 19, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    K953124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A POSTERIOR FOSSA CRANIOTOMY WAS BEING PERFORMED WITH THE USE OF A MAYFIELD 2000 SKULL CLAMP. THE PT WAS POSITIONED PRONE IN PINS BY THE SURGEON. THE PT WAS DRAPED, AN INCISION WAS MADE, AND SURGERY HAD BEGUN. THE LENGTH OF TIME IN USE BEFORE THE EVENT OCCURRED WAS APPROXIMATELY 30 MINUTES WHEN THE PT'S HEAD MOVED. THE PT'S POSITION WAS NOT CHANGED AT ANY TIME PRIOR TO THE INCIDENT. THE STAFF STABILIZED THE CHILD'S HEAD AND THE MAYFIELD WAS REAPPLIED AND REPOSITIONED. THERE WAS NO INJURY TO THE CHILD. THE NURSE PROVIDED THE FOLLOWING: "THE TUMOR WAS REMOVED, BUT WE WERE INITIALLY SET UP TO USE THE STEALTH SYSTEM, WHICH WOULD HAVE PROVIDED A HIGHER STANDARD OF CARE FOR THIS CHILD (AND THE STANDARD OF CARE WE ARE USED TO PROVIDING HERE AT THE HOSPITAL) AND CERTAINLY A MORE PRECISE LOCATION OF THE TUMOR WOULD HAVE BEEN OBTAINED, HAD WE NOT HAD THE MAYFIELD SLIP". DISPOSABLE ADULT MAYFIELD SKULL PINS ((B)(4)) WERE USED FOR THIS PROCEDURE. ADULT PINS WERE USED AS THE CHILD WAS (B)(6) AND APPROPRIATELY SIZED FOR HIS AGE. A STEREOTAXY DEVICE WAS NOT USED DURING THIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD 2000 SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR