BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD 2000 RADIOLUCENT SKULL CLAMP

    MDR report key: 2822493 · Received November 2, 2012

    Report

    Report Number
    3004608878-2012-00196
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 8, 2012
    Report Date
    November 2, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    K953124
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    A MAYFIELD 2000 SKULL CLAMP HAD SLIPPAGE CAUSING A LARGE LACERATION TO A PATIENT. THE LACERATION WAS STAPLED AND THE PINS WERE REAPPLIED TO THE PATIENT. THIS MALFUNCTION DELAYED THE CASE, BUT THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD 2000 RADIOLUCENT SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention