BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER SPINE

    MDR report key: 4491668 · Received February 2, 2015

    Report

    Report Number
    MW5040616
    Event Type
    Malfunction
    Date Received
    February 2, 2015
    Date of Event
    December 30, 2014
    Report Date
    February 2, 2015
    Manufacturer
    STYRKER
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT L5 KYPHOPLASTY FOR VERTEBRAL COMPRESSION FRACTURE. DURING REMOVAL OF THE RIGHT BALLOON, THE BALLOON BURST SPREADING CONTRAST IN THE FIELD AND MAKING IT DIFFICULT TO SEE THE ANATOMIC OUTLINES. THERE WAS NO SIGNIFICANT EXTRAVASATION AND APPROX. 8 ML OF CEMENT WAS DEPLOYED INTO THE L5 VERTEBRAL BODY. THE WORKING CHANNELS WERE REMOVED, AND THE SKIN WAS CLOSED WITH A SINGLE NYLON STITCH IN EACH STAB INCISION. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76472 STRYKER SPINE BONE CEMENT AND BALLOON NDN STYRKER VJU044

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR