BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIALIF

    MDR report key: 1434668 · Received August 7, 2009

    Report

    Report Number
    3004578806-2009-00017
    Event Type
    Injury
    Date Received
    August 7, 2009
    Date of Event
    July 9, 2009
    Report Date
    July 9, 2009
    Manufacturer
    TRANS1 INCORPORATED
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CODE WAS SELECTED WITH "OTHER" MEANING THAT THE TRAINING, LABELING, AND REPORTED DETAILS WERE EVALUATED. THERE WAS NO EVIDENCE OF OUT OF SPEC CONDITION THAT COULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    POSSIBLE BOWEL INJURY TREATED WITH DIVERTING COLOSTOMY. ACTUAL INJURY WAS NOT LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIALIF ANTERIOR SPINAL FIXATION JDN TRANS1 INCORPORATED 043116207D

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention