BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAK LUMBAR CAGE

    MDR report key: 498208 · Received November 12, 2003

    Report

    Report Number
    MW1030231
    Event Type
    Injury
    Date Received
    November 12, 2003
    Date of Event
    October 24, 2000
    Report Date
    November 12, 2003
    Manufacturer
    SPINE-TECH
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2000 PT HAD A SPINAL FUSION USING SPINE TECH'S BAK LUMBAR CAGES AT LEVELS L4-5, L5-S1. BONE WAS REMOVED FROM LEFT ILIAC CREST TO PROVIDE BONE GRAFT FOR FUSION. PT HAD A FIVE DAY HOSP STAY AT WHICH TIME THEY WERE RELEASED AND SENT HOME WITH SPECIFIC INSTRUCTIONS ON HOW TO SPEED THEIR RECOVERY, WHICH THEY FOLLOWED. PT HAD FOLLOW UP APPOINTMENTS WITH DR OF 1,3,6,9,12,18,24, AND 36 MONTHS. EACH TIME THE DR TOOK X-RAYS OF FUSION AND TOLD PT THAT SPINE LOOKED GOOD AND THAT THE FUSION LOOKED NORMAL. IT WAS NOT UNTIL 36 MONTH AFTER REPEATED COMPLAINTS ABOUT LOWER BACK PAIN AND LEG PAIN THAT THE DR CONFESSED THAT THE FUSION ATTEMPT HAD BEEN UNSUCCESSFUL. HE ORDERED AN MRI TO CONFIRM THE DIAGNOSIS, WHICH SHOWED A NON UNION OF L4-5,L5-S1. HE THEN INFORMED PT OF OPTIONS. THEY WERE TO UNDERGO ANOTHER SURGERY TO CORRECT THE NON-FUSION. HE ALSO CONFESSED THAT HE HIMSELF HAD STOPPED DOING THIS PROCEDURE IN JANUARY OF 2001 BECAUSE OF ITS FAILURE RATE. PT SOUGHT OUT ANOTHER DR FOR A SECOND OPINION. THIS DR ORDERED A DISCOGRAM AND AN SI JOINT INJECTION. THE SI INJECTION WAS NEGATIVE, BUT THE DISCOGRAM CAME BACK POSITIVE FOR NON-FUSION OF L4-5,L5-S1. HE RECOMMENDED SURGERY TO CORRECT WITH A SIX MONTH RECOVERY PERIOD. HE ALSO INFORMED PT THAT THE USE OF BAK LUMBAR CAGES AT MULTIPLE LEVELS WAS UNSUCCESSFUL ON MULTIPLE LEVEL FUSIONS AND THAT AS EARLY AS 1998 HE HAD STOPPED USING THIS TECHNIQUE TO TREAT DEGENERATIVE DISC DISEASE. PT'S QUESTION IS THIS: WHAT ARE THEIR OPTIONS TO REPAIR BACK GIVEN THAT A FAILED DEVICE HAS ALREADY BEEN IMPLANTED IN THEM AND IS THERE ANY RECOURSE THAT A PT HAS AGAINST THE MANUFACTURER OF SUCH A DEVICE AND THE PHYSICAN THAT PERFORMED THE PROCEDURE.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 03/10/04: UPON INVESTIGATION IT HAS BEEN DETERMINED THAT THIS EVENT DOES NOT MEET THE REQUIREMENTS OF BEING A REPORTABLE EVENT. NON-FUSION DOES NOT CONSTITUTE A FAILURE OF THE BAK LUMBAR IMPLANT AND THERE IS NO INDICATION FROM THE DESCRIBED EVENT THAT THERE IS ANY FAILURE OF THE DEVICE. FUSION RATES, STATED IN THE DEVICE INSTRUCTIONS FOR USE, UNDER THE CLINICAL RESULTS SECTION, ARE NOT 100%. SUCCESSFUL FUSION, IN PART, DEPENDS ON THE PT'S PHYSIOLOGY AND MEDICAL HISTORY.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 03/10/04: UPON INVESTIGATION IT HAS BEEN DETERMINED THAT THIS EVENT DOES NOT MEET THE REQUIREMENTS OF BEING A REPORTABLE EVENT. NON-FUSION DOES NOT CONSTITUTE A FAILURE OF THE BAK LUMBAR IMPLANT AND THERE IS NO INDICATION FROM THE DESCRIBED EVENT THAT THERE IS ANY FAILURE OF THE DEVICE. FUSION RATES, STATED IN THE DEVICE INSTRUCTIONS FOR USE, UNDER THE CLINICAL RESULTS SECTION, ARE NOT 100%. SUCCESSFUL FUSION, IN PART, DEPENDS ON THE PT'S PHYSIOLOGY AND MEDICAL HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAK LUMBAR CAGE LUMBAR FUSION DEVICE MAX SPINE-TECH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Disability