BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1549564 · Received November 30, 2009

    Report

    Report Number
    3004608878-2009-00092
    Event Type
    Other
    Date Received
    November 30, 2009
    Report Date
    November 30, 2009
    Manufacturer
    INTEGRA-OHIO
    Product Code
    HBL
    Adverse Event
    Yes
    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 INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE THIRD REPORT FROM THE SAME FACILITY. (B)(4). A MAYFIELD SKULL CLAMP WAS INVOLVED IN A SLIPPAGE DURING A PATIENT PROCEDURE. THE REPORTER DESCRIBED THE EVENT AS; THE MAYFIELD SKULL CLAMP SLIPPED DURING A PROCEDURE WHICH RESULTED IN A LACERATION TO A PATIENT'S FOREHEAD. ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED AND THE INTEGRA-LIFE SCIENCE SALES REPRESENTATIVE HAS BEEN INSTRUCTED TO PROVIDE THIS FACILITY WITH IN SERVICE EDUCATION ABOUT HOW TO PROPERLY APPLY THE CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP NONE HBL INTEGRA-OHIO

    Patients

    Seq Age Sex Outcome Treatment
    1