BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1982749 · Received December 20, 2010

    Report

    Report Number
    3004608878-2010-00147
    Event Type
    Other
    Date Received
    December 20, 2010
    Date of Event
    November 10, 2010
    Report Date
    December 20, 2010
    Manufacturer
    INTEGRA-OHIO, INC.
    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 EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE PT'S HEAD WAS IMMOBILIZED WITH A THREE-POINT MAYFIELD SKULL CLAMP. DISPOSABLE PINS WERE USED. SIXTY POUNDS OF PRESSURE WAS APPLIED. THE TIGHTENING MECHANISM ON THE LEFT SIDE OF HEAD CLAMP FAILED. THE SWIVEL JOINT TURNED, LACERATING THE LEFT SIDE OF PT'S SCALP WITH TWO OF THE IMMOBILIZATION PINS. THE U-SHAPED LACERATION WAS ABOUT ONE INCH LONG. STAPLES WERE REQUIRED FOR CLOSURE. THE EVENT DID NOT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE. ADD'L CLINICAL INFO HAS BEEN REQUESTED. CROSS REFERENCED TO UF/IMPORTER REPORT NUMBER: (B)(4).

    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