BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIALIF 2L

    MDR report key: 1894397 · Received November 9, 2010

    Report

    Report Number
    3004578806-2010-00012
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 9, 2010
    Manufacturer
    TRANS1
    Product Code
    KWQ
    PMA / PMN Number
    K073643
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOWEL INJURY. TREATED WITH DIVERTING COLOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIALIF 2L ANTERIOR SPINAL FIXATION KWQ TRANS1

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization