BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIALIF SYSTEM

    MDR report key: 1102471 · Received August 8, 2008

    Report

    Report Number
    3004578806-2008-00021
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    January 11, 2008
    Report Date
    July 31, 2008
    Manufacturer
    TRANS1
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TRAINING, INSPECTION, LOT RECORDS, ETC. WERE EVALUATED.

    Description of Event or Problem · 1

    INFO REPORTED 2008 CONFIRMED THAT THE PT DID SUFFER AN INFECTION OF E. COLI REVEALED IN A BONE BIOPSY OF THE PT'S SACRUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIALIF SYSTEM ANTERIOR SPINAL FIXATION JDN TRANS1 043106007G

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization