BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1914368 · Received November 18, 2010

    Report

    Report Number
    3004608878-2010-00130
    Event Type
    Other
    Date Received
    November 18, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 18, 2010
    Manufacturer
    INTEGRA-OHIO INC
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 WAS PLACED IN A PRONE POSITION FOR A CERVICAL LAMINECTOMY AND FUSION. MAYFIELD DISPOSABLE ADULT STEEL SKULL PINS ((B)(4) WITH LOT# 1101085) WERE USED. NO STEREOTAXY DEVICE WAS USED DURING THE SURGERY. WITHIN TWO MINUTES OF PRODUCT USE, THE CLAMP FAILED. THERE WAS A SLIPPAGE OF THE SKULL CLAMP DURING POSITIONING OF THE PT. THE PT WAS TURNED IMMEDIATELY TO A SUPINE POSITION TO REPAIR THE LACERATION ON THE LEFT SIDE OF THE SCALP. FOUR STAPLES WERE REQUIRED TO CLOSE THE LACERATION. A DIFFERENT SKULL CLAMP WAS THEN USED.

    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 080631/091

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR