BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAXIS VUE

    MDR report key: 656955 · Received December 22, 2005

    Report

    Report Number
    1649384-2005-00073
    Event Type
    Malfunction
    Date Received
    December 22, 2005
    Report Date
    December 22, 2005
    Manufacturer
    ABBOTT SPINE
    Product Code
    MQP
    Removal / Correction Number
    1649384-11/02/05-0001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PRODUCT RECALL FOR TRAXIS VUE PEEK IMPLANTS (LOT# 2010292) WAS INITIATED ON 11/2/2005. DURING THE EXECUTION OF THIS RECALL, A SALES REP REPORTED THAT 3 TRAXIS VUE IMPLANTS FROM THE DEFECTIVE LOT MAY HAVE BEEN IMPLANTED DURING 2 SEPARATE SURGERIES. COMPLETE INFORMATION REGARDING THE TWO CASES WAS NOT AVAILABLE AND ACTUAL IMPLANTATION COULD NOT BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAXIS VUE TRAXIS VUE INTERVERTEBRAL IMPLANT MQP ABBOTT SPINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO