BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD RADIOLUCENT HEADREST SYSTEM

    MDR report key: 1062057 · Received June 13, 2008

    Report

    Report Number
    3004608878-2008-00032
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Report Date
    June 13, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 THERE WAS AN ISSUE WITH HEAD SLIPPAGE WITH THIS DEVICE. INTEGRA RECEIVED ADDITIONAL INFORMATION FROM RISK MANAGEMENT IN 2008. THERE WAS A "SLIPPAGE ISSUE" WITH THE DEVICE DURING SET-UP. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INJURY AND NO PATIENT INCIDENT REPORT WAS FILED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD RADIOLUCENT HEADREST SYSTEM NONE HBL INTEGRA LIFESCIENCES CORPORATION 977

    Patients

    Seq Age Sex Outcome Treatment
    1