BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXIALIF SYSTEM

    MDR report key: 1023521 · Received March 28, 2008

    Report

    Report Number
    3004578806-2008-00005
    Event Type
    Other
    Date Received
    March 28, 2008
    Date of Event
    August 17, 2007
    Report Date
    March 14, 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

    THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE. THERE ARE PRIOR INSTANCES OF SIMILAR EVENTS THAT HAVE BEEN REPORTED. THE MFR IS TAKING PREVENTIVE ACTIONS TO FURTHER ACCOMMODATE A WIDER VARIATION IN TECHNIQUE. THE MFR IS CONSIDERING POSSIBLE LABELING CLARIFICATION, DESIGN ENHANCEMENT, AND TRAINING ENHANCEMENT.

    Description of Event or Problem · 1

    INTRAOPERATIVE HYPOTENSION. MEDICATION USED TO RESTORE TO NORMAL BLOOD PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIALIF SYSTEM ANTERIOR SPINAL FIXATION JDN TRANS1 INC. 043101707D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention