BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIALIF

    MDR report key: 1562746 · Received December 15, 2009

    Report

    Report Number
    3004578806-2009-00025
    Event Type
    Injury
    Date Received
    December 15, 2009
    Date of Event
    November 3, 2009
    Report Date
    November 19, 2009
    Manufacturer
    TRANS1 INCORPORATED
    Product Code
    JDN
    PMA / PMN Number
    K073514
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TRAINING RECORDS OF SURGEON WERE CONFIRMED. THERE WAS NO EVIDENCE OF OUT OF SPECIFICATION CONDITION OR TECHNIQUE DEVIATION THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THIS INVESTIGATION IS INCONCLUSIVE AS TO THE CAUSE.

    Description of Event or Problem · 1

    POSSIBLE BOWEL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIALIF ANTERIOR SPINAL FIXATION JDN TRANS1 INCORPORATED 043127308C

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization