BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIALIF SYSTEM

    MDR report key: 715416 · Received May 10, 2006

    Report

    Report Number
    3004578806-2006-00006
    Event Type
    Malfunction
    Date Received
    May 10, 2006
    Date of Event
    April 12, 2006
    Report Date
    May 10, 2006
    Manufacturer
    TRANS1 INCORPORATED
    Product Code
    JDN
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUTTER FRACTURED DURING PROCEDURE. SURGEON UNSUCCESSFULLY ATTEMPTED TO REMOVE CUTTER TIP. TIP OF CUTTER WAS NOT REMOVED AND WAS LEFT IN THE DISC SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIALIF SYSTEM * JDN TRANS1 INCORPORATED NA 043202306

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other