BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXIALIF SYSTEM

    MDR report key: 839032 · Received April 10, 2007

    Report

    Report Number
    3004578806-2007-00010
    Event Type
    Other
    Date Received
    April 10, 2007
    Date of Event
    March 16, 2007
    Report Date
    March 20, 2007
    Manufacturer
    TRANS1 INCORPORATED
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CODE WAS SELECTED WITH "OTHER" MEANING THAT INSPECTION RECORDS, TESTING, LOT RECORDS, TRAINING, ETC WERE EVALUATED. THE RESULTS OF THIS INVESTIGATION POINT TO A DEVIATION FROM THE SURGICAL TECHNIQUE BEING THE MOST LIKELY CONTRIBUTOR TO THIS EVENT. THERE ARE OTHER INSTANCES OF SIMILAR EVENTS AT THE SAME FACILITY CURRENTLY UNDER INVESTIGATION. THE MFR IS REPORTING THOSE WHERE INTERVENTION WAS DONE TO RESTORE THE BLOOD PRESSURE. THIS EVENT TYPE APPEARS TO BE ISOLATED TO THIS FACILITY WHERE A SPECIFIC DEVIATION FROM THE SURGICAL TECHNIQUE IS BEING USED. THE MFG IS TAKING PREVENTIVE ACTION TO FURTHER ACCOMMODATE A WIDER VARIATION IN TECHNIQUE OF GRAFT DELIVERY. THE MFR IS CONSIDERING POSSIBLE LABELING CLARIFICATION, DESIGN ENHANCEMENT, AND TRAINING ENHANCEMENT.

    Description of Event or Problem · 1

    BLOOD PRESSURE DROPPED DRAMATICALLY DURING GRAFT INTRODUCTION STEPS OF PROCEDURE. ANESTHESIOLOGIST ADMINISTERED IV MEDICATION TO RECOVER BP WITHIN 30-60 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIALIF SYSTEM ANTERIOR SPINAL FIXATION JDN TRANS1 INCORPORATED NA 043235206

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention