BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1062061 · Received June 13, 2008

    Report

    Report Number
    3004608878-2008-00035
    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
    OR, 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 REPORTED THAT THE DEVICE WOULD NOT SLIDE APART WHEN ATTEMPTING TO REMOVE IT FROM THE PATIENT'S HEAD. IT WOULD NOT SLIDE APART. IT WAS DISCOVERED THAT THERE WAS A BURR WHERE THE METAL HAD CAUGHT IN THE MIDDLE. A MEMBER OF THE CLINICAL STAFF MODIFIED THE CLAMP BY GRINDING IT SMOOTH. ADDITIONAL INFORMATION FROM THE SALES REPRESENTATIVE AND THE FACILITY HAD BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP NONE HBL INTEGRA LIFESCIENCES CORPORATION A1059

    Patients

    Seq Age Sex Outcome Treatment
    1