BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 3884318 · Received May 26, 2014

    Report

    Report Number
    3004608878-2014-00064
    Event Type
    Malfunction
    Date Received
    May 26, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 23, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, IT WAS INITIALLY REPORTED THAT AN INCIDENT OCCURRED WITH AN A1059 SKULL. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014 WAS AS FOLLOWS; AN A1059 MAYFIELD SKULL CLAMP WAS BEING USED FOR A C6T5 POSTERIOR INSTRUMENTAL FUSION WHEN THE PATIENT'S HEAD "DROPPED" OUT OF THE PINS. THERE WAS NO INJURY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309909 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA 006807

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR