BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORADO INTERVERTEBRAL BODY CAGE

    MDR report key: 1419405 · Received July 21, 2009

    Report

    Report Number
    3005977257-2009-00002
    Event Type
    Injury
    Date Received
    July 21, 2009
    Date of Event
    June 10, 2009
    Report Date
    July 21, 2009
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    MAX
    PMA / PMN Number
    K072289
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVAL. LOT HISTORY AND RETAINED DEVICES EVALUATED AND FOUND TO MEET QUALITY REQUIREMENTS. PRODUCT LABELING REVIEWED AND FOUND TO DESCRIBED PT SELECTION AND SUFFICIENTLY WARNS THAT USE IN PTS WITH PROGRESSIVE DEGENERATIVE CHARACTERISTICS MAY ADVERSELY AFFECT THE DEVICE'S ABILITY TO MEET PERFORMANCE REQUIREMENTS. CAUSE OF EVENT DETERMINED TO BE THE PRIOR CONDITION OF THE ANTERIOR LONGITUDINAL LIGAMENT. DEVICE'S CONTRIBUTION TO THE EVENT CANNOT BE FIRMLY CONCLUDED. REPORT IS BEING SUBMITTED DUE TO THE DEVICE'S INVOLVEMENT IN THE EVENT.

    Description of Event or Problem · 1

    DURING PLACEMENT OF THE INTERBODY FUSION DEVICE AT L5-S1 IT WAS NOTED THAT THE PT HAD SEVERE OSTEOPOROSIS AND AN INCOMPETENT ANTERIOR LONGITUDINAL LIGAMENT (ALL). BONE GRAFT WAS PACKED INTO THE ANTERIOR AREA TO ACT AS A STOP FOR THE INTERBODY. UPON INSERTION OF THE IMPLANT, THE INTERBODY WAS PUSHED THROUGH THE ALL INTO THE PERITONEAL SPACE. DEVICE WAS NOT RETRIEVED. PROCEDURE WAS REPEATED WITH A LARGER INTERBODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORADO INTERVERTEBRAL BODY CAGE INTERVERTERBAL BODY FUSION DEVICE MAX SPINEFRONTIER, INC. IM2002 802TI

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other