BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1071360 · Received July 7, 2008

    Report

    Report Number
    3004608878-2008-00044
    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
    FL, 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 THE DEVICE WAS "NOT HOLDING THE HEAD". 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 024

    Patients

    Seq Age Sex Outcome Treatment
    1