BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 3925652 · Received June 17, 2014

    Report

    Report Number
    3004608878-2014-00096
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 21, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 PATIENT WAS IN THE PRONE POSITION AND IN THE A1059 SKULL CLAMP FOR A SUBOCCIPITAL TUMOR RESECTION. THE PHYSICIAN WAS PREPARING TO USE A PERFORATOR AND WHEN HE APPLIED PRESSURE THE HEAD SHIFTED FROM FLEXION TO EXTENSION. THEN HE PULLED UP THE DRAPE AND DECIDED HE WOULD REPOSITION THE PT. "THE PTS' HEAD WAS REPOSITIONED A SECOND TIME THROUGH THE DRAPE AND IT WAS DISCOVERED THEN THE PT GOT LACERATED." THERE WAS NO DELAY IN THE SURGERY AS THE PROBLEM OCCURRED INTRAOPERATIVELY. A ONE (1) INCH LACERATION OCCURRED WHICH REQUIRED STAPLING TO THE LEFT TEMPORAL AREA. ADULT, DISPOSABLE PINS (#A1072) WERE USED DURING THE PROCEDURE. NO STEREOTACTIC DEVICE WAS USED AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356467 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA 000620

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R