BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIALIF SYSTEM

    MDR report key: 709520 · Received May 5, 2006

    Report

    Report Number
    3004578806-2006-00005
    Event Type
    Injury
    Date Received
    May 5, 2006
    Date of Event
    April 6, 2006
    Report Date
    May 5, 2006
    Manufacturer
    TRANS1 INCORPORATED
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT EXPERIENCING NUMBNESS IN BIG TOE AND PAIN. ROD ANGLED FROM ANTERIOR TO POSTERIOR AND APPEARS ON X-RAY TO PROTRUDE INTO SPINAL CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIALIF SYSTEM ANTERIOR SPINAL FIXATION JDN TRANS1 INCORPORATED NA 043232605

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R