BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER SPINE

    MDR report key: 4540977 · Received February 13, 2015

    Report

    Report Number
    MW5040849
    Event Type
    Malfunction
    Date Received
    February 13, 2015
    Date of Event
    February 6, 2015
    Report Date
    February 13, 2015
    Manufacturer
    STRYKER SPINE
    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

    PT UNDERWENT T12 KYPHOPLASTY FOR COMPRESSION FRACTURE. WHILE DILATING THE BALLOON WITH UP TO 400 PSI THERE WAS AN OPENING OF THE BALLOON ALONG THE POSTERIOR HALF OF THE CHANNEL BUT NOT THE ANTERIOR HALF. THE BALLOON WAS WITHDRAWN. THERE WERE NO EXTRAVASATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109612 STRYKER SPINE BONE CEMENT AND BALLOON NDN STRYKER SPINE VJU044

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR