BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1231323 · Received October 24, 2008

    Report

    Report Number
    3004608878-2008-00092
    Event Type
    Malfunction
    Date Received
    October 24, 2008
    Report Date
    October 24, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE USER FACILITY ORIGINALLY REPORTS A PATIENT INJURY WHEN THE DEVICE WAS IN CONTACT WITH THE PATIENT. ADDITIONAL INFORMATION: THE NEURO NURSE MANAGER REPORTED THAT DURING A PEDIATRIC NEUROSURGICAL PROCEDURE THERE WAS MOVEMENT UNDER THE DRAPES, AND THEY FOUND THE "DEVICE UNLOCKED". SHE CONFIRMED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP MAYFIELD CLAMP HBL INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1