BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD TRIAD SKULL CLAMP

    MDR report key: 1914313 · Received November 16, 2010

    Report

    Report Number
    3004608878-2010-00127
    Event Type
    Other
    Date Received
    November 16, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 16, 2010
    Manufacturer
    INTEGRA-OHIO, INC.
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    IT WAS REPORTED THAT THE PT WAS PLACED IN A PRONE POSITION FOR A CERVICAL LAMINECTOMY. WITHIN FIVE TO TEN MINUTES OF PRODUCT USE, THE SKULL CLAMP CAME OPEN AND THE ADULT DISPOSABLE PINS (UNK TYPE) CUT THE SCALP OF THE PT. SUTURES WERE REQUIRED. A NEW MAYFIELD WAS THEN USED AND SURGERY PROCEEDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR