BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIALIF

    MDR report key: 2083508 · Received May 10, 2011

    Report

    Report Number
    3004578806-2011-00004
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    March 29, 2010
    Report Date
    April 14, 2010
    Manufacturer
    TRANS1
    Product Code
    KWQ
    PMA / PMN Number
    K073514
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE WEIGHT, GENDER AND AGE OF THE PATIENT IS NOT KNOWN TO THE MANUFACTURER. THE GENERAL HISTORY OF SIMILAR DEVICES FROM CONTROLLED INVENTORY WAS CONSIDERED.

    Description of Event or Problem · 1

    POSSIBLE BOWEL INJURY. PATIENT TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIALIF ANTERIOR SPINAL FIXATION KWQ TRANS1 25-3007 043127308F

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization