BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXIALIF SYSTEM

    MDR report key: 1063709 · Received June 20, 2008

    Report

    Report Number
    3004578806-2008-00014
    Event Type
    Other
    Date Received
    June 20, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 22, 2008
    Manufacturer
    TRANS1 INC.
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION RECORDS, TESTING, LOT RECORDS, TRAINING, ETC. WERE EVALUATED.

    Description of Event or Problem · 1

    INTRAOPERATIVE HYPOTENSION WHERE INTERVENTION WAS DONE TO RESTORE BLOOD PRESSURE. EVENT RESOLVED IMMEDIATELY UPON ADMINISTRATION OF IV MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIALIF SYSTEM ANTERIOR SPINAL FIXATION JDN TRANS1 INC. 043116207B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention