BEUDAMED
    FDA Adverse Event Other Summary report: N

    IN-MOTION LUMBAR ARTIFICIAL DISC, SIZE UNK

    MDR report key: 1669210 · Received April 21, 2010

    Report

    Report Number
    1526439-2010-00060
    Event Type
    Other
    Date Received
    April 21, 2010
    Date of Event
    April 7, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MJO
    PMA / PMN Number
    P040006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT OF THIS NATURE (VASCULAR DAMAGE) IS AN INHERENT RISK OF ANTERIOR LUMBAR SURGERY. AS REPORTED THE ROOT CAUSE APPEARS TO BE DUE TO THE ACCESS RETRACTORS USED IN THE CASE COMING INTO CONTACT WITH THE VASCULAR STRUCTURE. THE EVENT AS REPORTED WAS NOT ATTRIBUTED TO THE DEPUY SPINE IN-MOTION IMPLANT OR INSERTION INSTRUMENTS.

    Description of Event or Problem · 1

    PROCEDURE WAS AN L4-5 TOTAL DISC ARTHROPLASTY WITH THE CHARITE ARTIFICIAL DISC. WHILE MOVING TO A LATERAL C-ARM POSITION, THE VASCULAR FELLOW NOTICED COPIOUS AMOUNTS OF VENOUS BLOOD IN THE ACCESS WOUND. A MEMBER OF THE OPERATING ROOM STAFF WAS HOLDING 2 RETRACTORS WITH POSTERIOR LIPS. THESE RETRACTORS WERE HOLDING THE INCISION ACCESS OPENING AND IT'S MUSCULAR AND VASCULAR ANATOMY, SO VISUALIZATION OF THE L4-5 DISC WAS POSSIBLE. THE INSTRUMENT TO DELIVER THE IMPLANT WAS REMOVED, AND THE VASCULAR TEAM WORKED TO CONTAIN AND CONTROL THE BLEEDING. ALL MEASURES WERE EXHAUSTED AND UNFORTUNATELY OUTCOME COULD NOT BE REVERSED. AUTOPSY REVEALED A TEAR ON THE POSTERIOR WALL OF THE AORTA, BELIEVED TO BE FROM THE RETRACTORS. THE EVENT WAS NOT ATTRIBUTABLE TO THE DEPUY SPINE IMPLANT OR INSTRUMENT; HOWEVER, WE ARE TAKING A CONSERVATIVE APPROACH AND FILING AN MDR TO DOCUMENT THIS ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IN-MOTION LUMBAR ARTIFICIAL DISC, SIZE UNK LUMBAR ARTIFICIAL DISC MJO DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR