BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 3221858 · Received July 9, 2013

    Report

    Report Number
    3004608878-2013-00131
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE DEVICE WAS ORIGINALLY SENT TO INTEGRA ON (B)(6) 2013 FOR REPAIR. NO OTHER INFORMATION PROVIDED. ON (B)(6) 2013, THE SALES REPRESENTATIVE REPORTED A POSSIBLE SLIPPAGE WITH THE DEVICE. THE SLIPPAGE WAS CONFIRMED ON (B)(6) 2013 BY THE SALES REPRESENTATIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312669 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA 121

    Patients

    Seq Age Sex Outcome Treatment
    1