BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD SKULL CLAMP

    MDR report key: 1190688 · Received October 3, 2008

    Report

    Report Number
    3004608878-2008-00082
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Report Date
    October 3, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE DEVICE SLIPPED WHILE THE PATIENT WAS BEING CLAMPED IN. THIS UNIT DID COME INTO CONTACT WITH A PATIENT. REQUESTED ADDITIONAL INFORMATION FROM THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD SKULL CLAMP NONE HBL INTEGRA LIFESCIENCES CORPORATION 979

    Patients

    Seq Age Sex Outcome Treatment
    1