BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 2214109 · Received July 20, 2011

    Report

    Report Number
    3004608878-2011-00098
    Event Type
    Other
    Date Received
    July 20, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 20, 2011
    Manufacturer
    INTEGRA, CINCINNATI
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A MAYFIELD SKULL CLAMP WAS PLACED ON A PT WHO WAS PINNED TO THE CLAMP PRIOR TO PRONE POSITIONING. THE PT WAS THEN TRANSFERRED FROM THE STRETCHER TO THE OPERATING ROOM TABLE TO THE PRONE POSITION. PRIOR TO SECURING THE SKULL CLAMP, THE LOCK ON THE CLAMP SLIPPED CAUSING THE SKULL PIN TO LACERATE THE PTS' OCCIPITAL AREA. THE SKULL CLAMP WAS REMOVED AND SWITCHED TO ANOTHER SKULL CLAMP. THE PT WAS POSITIONED WITHOUT DIFFICULTY. THE LACERATION WAS IRRIGATED AND CLEANED WITH BETADINE AND THEN SUTURED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention