BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 2043297 · Received February 25, 2011

    Report

    Report Number
    3004608878-2011-00020
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 25, 2011
    Manufacturer
    INTEGRA-OHIO, INC.
    Product Code
    HBL
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 PT WAS PREPPED AND DRAPED AND HAD A MAYFIELD SKULL CLAMP APPLIED FOR AN ANTERIOR CERVICAL PROCEDURE. THERE WAS PRESSURE EXERTED ON THE PT'S HEAD AND THE FRAME OF THE UNIT WHEN THE UNIT SLIPPED. THERE WAS NO INJURY OR DELAY IN THE SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1