BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1031363 · Received April 18, 2008

    Report

    Report Number
    3004608878-2008-00015
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Report Date
    April 17, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE HOSPITAL WAS UNSURE IF THE LOCK WAS IN THE CORRECT POSITION. IT WAS REPORTED THAT THE DEVICE FELL ON THE PATIENT, AND THE PATIENT WAS INJURED. WHEN CONTACTED, HOSPITAL REPRESENTATIVES DENIED THAT THERE WAS ANY INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP NONE HBL INTEGRA LIFESCIENCES CORPORATION 071

    Patients

    Seq Age Sex Outcome Treatment
    1