BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD INFINITY SKULL CLAMP

    MDR report key: 1900317 · Received October 25, 2010

    Report

    Report Number
    3004608878-2010-00114
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 25, 2010
    Manufacturer
    INTEGRA-OHIO, INC.
    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 FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    AS THE SURGEON WAS POSITIONING THE SKULL CLAMP TO THE PT FOR A CRANIOTOMY PROCEDURE, HE HAD DIFFICULTY LOCKING IT. ANOTHER PHYSICIAN HAD TO ASSIST IN HOLDING THE PT'S HEAD WHILE THE SURGEON TURNED THE KNOB USING BOTH HANDS TO LOCK IT. THERE WAS NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1