BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORADO INTERVERTEBRAL BODY CAGE

    MDR report key: 1368785 · Received April 23, 2009

    Report

    Report Number
    3005977257-2009-00001
    Event Type
    Injury
    Date Received
    April 23, 2009
    Date of Event
    March 18, 2009
    Report Date
    April 22, 2009
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    MAX
    PMA / PMN Number
    K072289
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    PATIENT UNDERWENT IBF AND FIXATION AT L5-S1 IN 2009. PATIENT PRESENTED TWO WEEKS POST-OP WITH BOWEL AND BLADDER DISTURBANCES. EXAMINATION REVEALED RETROPULSION OF THE L5-S1 FUSION CAGE. PATIENT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORADO INTERVERTEBRAL BODY CAGE INTERVERTEBRAL BODY FUSION DEVICE MAX SPINEFRONTIER, INC. IM2005 985TI

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention