BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 2831755 · Received November 9, 2012

    Report

    Report Number
    3004608878-2012-00204
    Event Type
    Injury
    Date Received
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE SECOND REPORT OF TWO INVOLVING THE SAME PT AND THE SAME SKULL CLAMP. AFTER THE SKULL CLAMP WAS REAPPLIED THE UNIT SLIPPED A ONCE AGAIN. WHEN THIS OCCURRED THE PT INCURRED A LACERATION THAT REQUIRED SUTURING WITH NYLON. THE REPORTER FEELS THAT THE REASON THE PT SLIPPED WAS BECAUSE THE PT WAS POSITIONED INCORRECTLY FOR THE SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention