BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD TRIAD SKULL CLAMP

    MDR report key: 1061014 · Received June 12, 2008

    Report

    Report Number
    3004608878-2008-00036
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 16, 2008
    Report Date
    June 12, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE USER FACILITY FIRST REQUESTED ADDITIONAL UPDATED EDUCATION INFO REGARDING THE PROPER USE OF THE MAYFIELD TRIAD SKULL CLAMP, FOR THE CLINICAL EDUCATORS. THEIR INTENT WAS TO "MAKE SURE THE STAFF ARE ACQUAINTED WITH THE PROPER PROCEDURES FOR USING THE CLAMP." ANOTHER COPY OF THE INSTRUCTIONS FOR USE, AS WELL AS AN INSTRUCTIONAL POSTER/PLACKARD WERE PROVIDED. THIS REQUEST WAS THE RESULT OF AN INCIDENT WITH A SKULL CLAMP SLIPPING DURING POSITIONING A PT FOR SURGERY. A DISCUSSION WITH THE BIOMEDICAL ENGINEER REVEALED THAT THEIR RECORDS SHOWED THERE WAS NO SERIOUS INJURY TO THE PT. HOWEVER THERE WAS A SMALL LACERATION TO THE SCALP THAT REQUIRED "A FEW STITCHES." THE BIOMEDICAL ENGINEER EXAMINED THE SKULL CLAMP AND DETERMINED THERE WAS NOTHING WRONG WITH THE FUNCTION OF THE DEVICE, THEREFORE HE DID NOT RETURN TO THE DEVICE TO THE COMPANY. HE INDICATED THAT FURTHER EDUCATION OF ALL INVOLVED IN THE USE OF THE DEVICE WAS NECESSARY SO THAT IT WOULD BE PROPERLY APPLIED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD TRIAD SKULL CLAMP MAYFIELD CLAMP HBL INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1