BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIALIF SYSTEM

    MDR report key: 1041023 · Received May 9, 2008

    Report

    Report Number
    3004578806-2008-00010
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 8, 2008
    Manufacturer
    TRANS1 INC.
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    POSSIBLE BOWEL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIALIF SYSTEM ANTERIOR SPINAL FIXATION JDN TRANS1 INC. 043103006C

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization