BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIALIF SYSTEM

    MDR report key: 1051092 · Received May 22, 2008

    Report

    Report Number
    3004578806-2008-00013
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    March 31, 2008
    Report Date
    May 6, 2008
    Manufacturer
    TRANS1 INC
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TRAINING, MFG PROCESS, DESIGN, INSPECTION, TESTING, LOT RECORDS ETC., WERE EVALUATED.

    Description of Event or Problem · 1

    BOWEL INJURY TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIALIF SYSTEM ANTERIOR SPINAL FIXATION KWP TRANS1 INC 043106007J

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention