BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD 2000 SKULL CLAMP

    MDR report key: 1883235 · Received October 20, 2010

    Report

    Report Number
    3004608878-2010-00111
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 20, 2010
    Manufacturer
    INTEGRA LIFESCIENCES CORP. (INTEGRA-OHIO)
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA LIFESCIENCES ENGINEERS HAVE COMPLETED A THOROUGH INVESTIGATION OF THE MAYFIELD 2000 SKULL CLAMP AND THE RESULTANT FINDINGS ARE AS FOLLOWS; THE ROOT CAUSE IS WEAR ON THE HEX BUSHING FROM EXTENDED USE AND CLEANING AT ELEVATED TEMPERATURES. THIS UNIT WAS MANUFACTURED AND SOLD IN 2000 AND HAS NOT BEEN RETURNED FOR SERVICING PRIOR TO THIS EVENT.

    Description of Event or Problem · 1

    AN ADULT PATIENT WHOSE GENDER WAS NOT PROVIDED WAS PINNED WITH THE MAYFIELD (B)(4) SKULL CLAMP FOR A CRANIOTOMY. THE ROCKER ARM WAS FOUND TO HAVE MOVEMENT. SURGERY WAS NOT DELAYED AND THERE WAS NO INJURY INVOLVED. STEREOTAXY DEVICE WAS ALSO BEING USED WITH MAYFIELD ADULT PINS SERIAL NUMBER WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD 2000 SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORP. (INTEGRA-OHIO)

    Patients

    Seq Age Sex Outcome Treatment
    1