BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA 360 PATIENT POSITIONING SYSTEM

    MDR report key: 3181627 · Received June 14, 2013

    Report

    Report Number
    3004608878-2013-00114
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON EITHER (B)(6) 2013, THE SURGEON FELT EXCESSIVE PLAY/MOVEMENT IN THE MAYFIELD 360 BASE UNIT WHILE THE PT WAS IN THE PRONE POSITION DURING A POSTERIOR FOSSA CRANIOTOMY. THE SURGERY WAS STOPPED AND THE PT WAS REMOVED FROM THE MAYFIELD UNIT WHILE ANOTHER MAYFIELD SYSTEM WAS LOCATED. THE PT WAS THEN REPOSITIONED. THERE WAS NO PT INJURY OR DEATH ALLEGED. THE EVENT DID LEAD TO A 30 MIN INCREASE IN SURGERY TIME. ADDITIONAL INFO WAS REQUESTED AND THE FOLLOWING WAS PROVIDED ON (B)(6) 2013: THE FEMALE PT WAS PRONE AT ALL TIMES DURING A FORAMEN MAGNUM DECOMPRESSION. THE SURGERY HAS BEEN GOING ON FOR APPROX 20 MINS. THE SURGEON HAD JUST STARTED CUTTING INTO THE SKIN AND WHEN HE NOTICED THE MOVEMENT AND IMMEDIATELY PLACED HIS HAND UNDER THE PT'S HEAD TO SUPPORT IT WHILE ANOTHER MAYFIELD WAS OBTAINED AND INSTALLED. THE REPLACEMENT MAYFIELD UNIT WORKED AND SURGERY WAS ABLE TO BE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271012 ULTRA 360 PATIENT POSITIONING SYSTEM BASE UNITS AND ADAPTERS FWZ INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR