BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZIALIF SYSTEM

    MDR report key: 1066614 · Received June 27, 2008

    Report

    Report Number
    3004578806-2008-00016
    Event Type
    Injury
    Date Received
    June 27, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 6, 2008
    Manufacturer
    TRANS1 INCORPORATED
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CODE WAS SELECTED WITH "OTHER" MEANING THAT THE TRAINING, MANUFACTURING PROCESS, DESIGN, INSPECTION, TESTING, LOT RECORDS, ETC., WERE EVALUATED.

    Description of Event or Problem · 1

    UNCONFIRMED SUSPECTED BOWEL INJURY WITH ANTIBIOTICS AND TEMPORARY DIVERTING COLOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AZIALIF SYSTEM ANTERIOR SPINAL FIXATION JDN TRANS1 INCORPORATED 04313036C

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization