BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1071362 · Received July 7, 2008

    Report

    Report Number
    3004608878-2008-00051
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Report Date
    July 7, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE "CLAMP SLIPPED DURING A CASE." ATTEMPTING TO OBTAIN ADDITIONAL INFO FROM THE FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1