BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAXIS

    MDR report key: 648762 · Received November 30, 2005

    Report

    Report Number
    1649384-2005-00071
    Event Type
    Malfunction
    Date Received
    November 30, 2005
    Date of Event
    October 27, 2005
    Report Date
    November 30, 2005
    Manufacturer
    ABBOTT SPINE
    Product Code
    MQP
    Removal / Correction Number
    CR#1649384-11/2/05-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 RADIOOPAQUE 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 TRAXIS VUE INTERVERTEBRAL BODY CAGE MQP ABBOTT SPINE NA 2010292

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO