BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAXIS VUE

    MDR report key: 648285 · Received November 29, 2005

    Report

    Report Number
    1649384-2005-00069
    Event Type
    Malfunction
    Date Received
    November 29, 2005
    Date of Event
    September 22, 2005
    Report Date
    November 28, 2005
    Manufacturer
    ABBOTT SPINE
    Product Code
    KWQ
    Removal / Correction Number
    CR#1649384-11/2/05-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS ISSUE WAS IDENTIFIED DURING A PRODUCT RECALL FOR TRAXIS VUE LOT #2010292. THE TRAXIS VUE THAT WAS IMPLANTED DURING A LUMBAR FUSION DID NOT POSSESS THE RADIOPAQUE MARKERS NEEDED FOR MONITORING. THERE HAS NOT BEEN ANY INJURY OR REVISION SURGERY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAXIS VUE INTERVERTEBRAL BODY CAGE KWQ ABBOTT SPINE NA 2010292

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR