BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1943800 · Received December 20, 2010

    Report

    Report Number
    3004608878-2010-00146
    Event Type
    Other
    Date Received
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    INTEGRA OHIO
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA LIFESCIENCES ENGINEERS HAVE COMPLETED A THOROUGH INVESTIGATION OF THE RETURNED KIT. THE RETURNED UNIT PASSED ALL REQUIRED FUNCTIONAL/PERFORMANCE TESTING AS RECEIVED. THEREFORE THE ROOT CAUSE IS NOT RELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    A MAYFIELD SKULL CLAMP (B)(4) SLIPPED DURING A PROCEDURE AND THE PT INCURRED A LACERATION. ADDITIONAL CLINICAL INFO WAS REQUESTED HOWEVER, NONE WAS PROVIDED AND IS NOT EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA OHIO

    Patients

    Seq Age Sex Outcome Treatment
    1