BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIALIF SYSTEM

    MDR report key: 1345562 · Received March 17, 2009

    Report

    Report Number
    3004578806-2009-00009
    Event Type
    Injury
    Date Received
    March 17, 2009
    Date of Event
    February 4, 2009
    Report Date
    February 23, 2009
    Manufacturer
    TRANS1 INCORPORATED
    Product Code
    JDN
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON NOR THE HOSPITAL HAVE INDICATED TO THE HOSPITAL WHETHER OR NOT THEY INTEND TO REPORT THIS EVENT. LOT RECORDS, TRAINING, LABELING, ETC. WERE VERIFIED. THERE IS NO EVIDENCE OF ANY OUT OF SPECIFICATION CONDITION FOR PRODUCT USED IN THIS CASE. IT SHOULD BE NOTED THAT THE GENERAL SURGEON DIAGNOSED A BOWEL INJURY BUT THE SPINE SURGEON IS NOT COMPLETELY CONVINCED THAT ANY INJURY EXISTS. DURING THE CASE, THE EXCHANGE CANNULA CAME SLIGHTLY OFF OF THE FACE OF THE SACRUM AND WAS NOT REPLACED. THE IMPLANT WAS DELIVERED ACROSS THIS GAP. IT CANNOT BE RULED OUT THAT AN INJURY COULD OCCUR IN THIS SCENARIO.

    Description of Event or Problem · 1

    SUSPECTED BOWEL INJURY TREATED WITH TEMPORARY DIVERTING COLOSTOMY. GENERAL SURGEON DIAGNOSED A SMALL INJURY NEAR THE SACRAL FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIALIF SYSTEM ANTERIOR SPINAL FIXATION JDN TRANS1 INCORPORATED 043620708G

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization