BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE MR/CT SKULL CLAMP

    MDR report key: 2122075 · Received May 24, 2011

    Report

    Report Number
    3004608878-2011-00074
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    INTEGRA - CINCINNATI
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AN ADULT SMALL ROCKER ARM OF A GE MR/CT SKULL CLAMP BROKE AT THE END OF SURGERY. THE PT WAS NOT IN CONTACT WITH THE UNIT WHEN THE EVENT OCCURRED. THERE WAS NO INJURY OR DELAY INVOLVED WITH THIS COMPLAINT. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE MR/CT SKULL CLAMP NA HBL INTEGRA - CINCINNATI

    Patients

    Seq Age Sex Outcome Treatment
    1