BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1914351 · Received November 17, 2010

    Report

    Report Number
    3004608878-2010-00126
    Event Type
    Other
    Date Received
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    INTEGRA OHIO
    Product Code
    HBL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A MAYFIELD SKULL CLAMP WAS INVOLVED IN AN INCIDENT DURING A PROCEDURE AND WAS DESCRIBED AS FOLLOWS; THE SKULL PIN ON THE TORQUE KNOB PENETRATED THE PT'S SKULL DURING A PROCEDURE. ADDITIONAL CLINICAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1