BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 2150761 · Received June 21, 2011

    Report

    Report Number
    3004608878-2011-00082
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    INTEGRA, CINCINNATI
    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 RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE PT WAS IN A PRONE POSITION FOR A POSTERIOR CERVICAL SPINE SURGERY. THE SWIVEL LOCK WAS LOCKED. THE SKULL CLAMP WAS GRIPPED VIA TWO UPRIGHT SUPPORTS. WHEN THE CLAMP WAS MOVED BY THE USER TO EXPOSE THE CERVICAL AREA, THE CLAMP ROTATED. THE PT'S CHIN ROTATED TOWARDS THE CHEST. THE SWIVEL LOCK ROTATED ABOUT THE 80 POUND TORQUE KNOB AXIS WHILE IN THE LOCKED POSITION. THE PT'S HEAD DID NOT MOVE. THE SKULL PINS WERE STILL SEATED. NO PT LACERATION OR INJURY WAS REPORTED. THE PRODUCT WAS USED LESS THAN FIVE MINS BEFORE THE EVENT OCCURRED. THE SKULL CLAMP WAS REMOVED AND A NEW SKULL CLAMP WAS APPLIED, WHICH WORKED PROPERLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1