BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIALIF SYSTEM

    MDR report key: 961251 · Received December 6, 2007

    Report

    Report Number
    3004578806-2007-00024
    Event Type
    Injury
    Date Received
    December 6, 2007
    Date of Event
    November 26, 2007
    Report Date
    November 29, 2007
    Manufacturer
    TRANS1 INCORPORATED
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR HAS NOT TO DATE RECEIVED FORM 3500 FROM THE USER FACILITY. THE MANUFACTURING PROCESS, DESIGN, INSPECTION, TESTING, LOT RECORDS, TRAINING RECORDS, ETC. WERE EVALUATED.

    Description of Event or Problem · 1

    BOWEL INJURY NEAR INCISION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIALIF SYSTEM ANTERIOR SPINAL FIXATION JDN TRANS1 INCORPORATED NA 044221307

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R