BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD TRIAD SKULL CLAMP

    MDR report key: 1883149 · Received October 19, 2010

    Report

    Report Number
    3004608878-2010-00107
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 19, 2010
    Manufacturer
    INTEGRA-OHIO, INC
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS INVOLVING A MAYFIELD TRIAD SKULL CLAMP (SAME PT, SAME FACILITY, SAME PRODUCT BUT A DIFFERENT LOT NUMBER). THE PT WAS POSITIONED IN A PRONE POSITION FOR A POSTERIOR CERVICAL FUSION. THE CLAMP WAS APPLIED ALONG THE "SWEATBAND" AREA WITH 60 POUNDS OF PRESSURE. THE ROCKER PINS WERE BALANCED WITH A WRENCH. DISPOSABLE MAYFIELD ADULT PINS WERE USED. DURING POSITIONING, THE GEARS WITHIN THE SWIVEL LOCK "GAVE" AND THE BASE OF THE CLAMP MOVED APPROX SIX INCHES TOWARDS PT'S NOSE. THE CLAMP WAS REMOVED. THE LENGTH OF TIME IN USE BEFORE THE EVENT OCCURRED WAS RIGHT AFTER THE PT WAS POSITIONED. THERE WAS BLEEDING NOTED DUE TO THE PIN INSERTION. STAPLES WERE USED FOR CLOSURE. THERE WAS NO LACERATION REPORTED. A SECOND AND THIRD CLAMP WAS USED. CROSS REFERENCED TO MFR REPORT NUMBER 3004608878-2010-00108.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD TRIAD SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA-OHIO, INC 101

    Patients

    Seq Age Sex Outcome Treatment
    1