BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1993371 · Received February 8, 2011

    Report

    Report Number
    3004608878-2011-00014
    Event Type
    Other
    Date Received
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    INTEGRA OHIO
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    A MAYFIELD SKULL CLAMP WAS INVOLVED IN A SLIPPAGE DURING USE WHICH RESULTED IN A LACERATION TO THE PT. THE REPORTER COULD NOT PROVIDE ANY ADDITIONAL INFORMATION ABOUT THE PT, EVENT DATE OR ANOTHER CONTACT PERSON WHO COULD PROVIDE CLINICAL INFORMATION. ADDITIONAL INFORMATION IS NOT EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA OHIO 104

    Patients

    Seq Age Sex Outcome Treatment
    1