BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARITE ARTIFICIAL DISC, SIZE UNK

    MDR report key: 2130415 · Received June 13, 2011

    Report

    Report Number
    1526439-2011-00098
    Event Type
    Injury
    Date Received
    June 13, 2011
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MJO
    PMA / PMN Number
    P040006
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRE-OP: ON (B)(6) 2005 CT SHOWS DISC BULGING AT L4-L5. ON (B)(6) 2004 MRI SHOWS MILD OSTEOARTHRITIC CHANGES L4-L5 AND L5-S1 FACETS. ON (B)(6) 2005 DISK DEGENERATION L4-L5, L5-S1 WITH DISCOGRAPHY CONCORDANT PAIN. CHARITE DISCS IMPLANTED AT L4-L5, L5-S1 ON (B)(6) 2005. POST-OP: ON (B)(6) 2005 PATIENT DOING WELL; X-RAYS SHOW DISCS IN VERY GOOD POSITION AND MOBILE, MODERATE FACET HYPERTROPHY. ON (B)(6) 2005 PATIENT DOING WELL, X-RAYS SHOW IMPLANTS ENGAGED, GOOD RESTORATION OF DISC HEIGHT. ON (B)(6) 2006 X-RAYS SHOW NO HARDWARE FAILURE OR MECHANICAL LOOSENING, GOOD DISC ALIGNMENT. NOTED BRIDGING OSTEOPHYTE AT L4-L5, VERTEBRAL BODIES DEMONSTRATE PATTERN CONSISTENT WITH OSTEOPENIA. ON (B)(6) 2007 CT SHOWS BRIDGING OSTEOPHYTE AT L4-L5, FACET ARTHROPATHY OF L4-L5 AND L5-S1. ON (B)(6) 2007 BACK PAIN REPORTED. ON (B)(6) 2007 CT IS UNCHANGED SINCE (B)(6) 2007. ON (B)(6) 2008 X-RAYS SHOW NO FRACTURE, BONE DESTRUCTION OR SIGNIFICANT SUBLUXATION, MILD OSTEOPENIA AND MINIMAL S-SHAPED CURVATURE. ON (B)(6) 2008 CT SHOWS DISC AT L5-S1 CENTERED, DISC AT L4-L5 EXTENDING BEYOND ANTERIOR MARGINS. NOTES FACET ARTHROPATHY. ON (B)(6) 2009 X-RAYS SHOW SLIGHT ANTERIOR DISPLACEMENT OF DISC AT L4-L5 HOWEVER STABLE SINCE (B)(6) 2008 . ON (B)(6) 2009 X-RAYS SHOW PARTIAL SUBLUXATION L4-L5, THE TEETH OF THE DISK ON THE ENDPLATES FOR THE ANTERIOR ARE BEYOND THE VERTEBRAL MARGIN ANTERIORLY AND POSTERIOR TO THIS SUBCHONDRAL SCLEROSIS AND THE DISC SPACE IS NARROWING. ON (B)(6) 2009 REVISION DUE TO INCREASED AND CONSTANT PAIN, REVISION WITH FACET DECOMPRESSION AND PLF WITH PEDICLE SCREWS/RODS L4-L5 AND L5-S1. CHARITE DISCS LEFT IN VIVO. NOTE: USING TWO CHARITE IMPLANTS IN ONE PATIENT IS AN OFF LABEL USE. CHARITE IS APPROVED FOR USE AS A ONE LEVEL IMPLANT ONLY. SURGEON IMPLANTED TWO DISCS. THIS GOES AGAINST THE INFORMATION THAT IS RECOMMENDED IN THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH EACH DEVICE.

    Description of Event or Problem · 1

    DEPUY SPINE BECAME AWARE OF A CHARITE ARTIFICIAL DISC PATIENT WHO EXPERIENCED AN ADVERSE OUTCOME AFTER PLACEMENT. AS A RESULT AN MDR IS FILED TO DOCUMENT THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1