BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD TRIAD SKULL CLAMP

    MDR report key: 3221853 · Received July 9, 2013

    Report

    Report Number
    3004608878-2013-00129
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    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 FIR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A1108 TRIAD SKULL CLAMP WAS REPORTED TO HAVE SLIPPED ON A PT CAUSING A "CUT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312522 MAYFIELD TRIAD SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1