BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1022101 · Received March 25, 2008

    Report

    Report Number
    3004608878-2008-00013
    Event Type
    Malfunction
    Date Received
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE INCIDENT HAS BEEN RECEIVED FOR EVAL, AND AN INVESTIGATION HAS BEEN INITIATED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE MAYFIELD SKULL CLAMP SLIPPED WHILE IN USE. THE RPTR STATES THAT "THE PROBLEM WAS NOT WITH THE EQUIPMENT BUT THE SURGEON." INTEGRA LIFE SCIENCES RECEIVED ADD'L INFO REGARDING THIS INCIDENT IN 2008. THE DETAILS ARE LISTED BELOW: MAYFIELD 3-PIN HEAD REST FELL OFF PT'S HEAD DESPITE BEING CORRECTLY APPLIED/TORQUED-UP, RESULTING IN A WHIPLASH-TYPE CERVICAL MOVEMENT AND SCALP LACERATION. THE HEAD LOST THE SUPPORT OF THE CLAMP AND FELL AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP MAYFIELD CLAMP HBL INTEGRA LIFESCIENCES CORPORATION 047

    Patients

    Seq Age Sex Outcome Treatment
    1