BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAXIS VUE

    MDR report key: 648295 · Received November 29, 2005

    Report

    Report Number
    1649384-2005-00067
    Event Type
    Malfunction
    Date Received
    November 29, 2005
    Date of Event
    October 26, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS ISSUE WAS IDENTIFIED DURING A PRODUCT RECALL FOR TRAXIS VUE LOT #2010292. IT WAS REPORTED THAT IN 2005 DURING A TLIF, THORACOLUMBAR INTERBODY FUSION, THE TRAXIS VUE IMPLANTS WERE FOUND TO BE WITHOUT RADIOGRAPHIC MARKERS. THERE WAS NO REPORTED INJURY OR PLANS FOR REVISION SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA