BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD SWIVEL ADAPTOR

    MDR report key: 3137693 · Received May 28, 2013

    Report

    Report Number
    3004608878-2013-00098
    Event Type
    Malfunction
    Date Received
    May 28, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 28, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A CRANIOTOMY/CRANIECTOMY USING BRAIN LAB GUIDANCE WAS BEING PERFORMED WHEN THE PT WAS PRONE. THE PT HAD NOT BEEN REPOSITIONED DURING THE PROCEDURE; APPARENTLY THE SWIVEL PIECE MOVED AFTER INITIALLY POSITIONING THE PT. THE SHIFT WAS NOT NOTICED UNTIL AFTER THE DRAPES CAME OFF AT THE END OF THE PROCEDURE. A REVISION WAS NOT REQUIRED AND THE PT WAS NOT INJURED IN ANY WAY AND HIS OUTCOME WAS GOOD. INTEGRA ADULT DISPOSABLE PINS (B)(4). PROBABLE LOT # OF 1123079 EXPIRES 07/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233306 MAYFIELD SWIVEL ADAPTOR SKULL PINS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1