BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 2982220 · Received November 10, 2005

    Report

    Report Number
    3004608878-2005-00003
    Event Type
    Malfunction
    Date Received
    November 10, 2005
    Report Date
    November 10, 2005
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE FOLLOWING INCIDENT WAS REPORTED BY THE DISTRIBUTOR: DURING THE FIXATION OF THE HEAD IN ¿LOCK¿ POSITION, THE PATIENT¿S HEAD SLID OUT OF THE 3 POINTS FIXATION AND CUT THE HEAD OF THE PATIENT. IT SEEMS THAT THE FIXATION OF THE PINS BECOME LOOSE, EVEN THOUGH THE FIXATION WAS IN ¿LOCK¿ POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP MAYFIELD SKULL CLAMP HBL INTEGRA LIFESCIENCES CORPORATION 044

    Patients

    Seq Age Sex Outcome Treatment
    1