BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAK TITANIUM CAGE

    MDR report key: 3713086 · Received March 26, 2014

    Report

    Report Number
    MW5035332
    Event Type
    Injury
    Date Received
    March 26, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Product Code
    MAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 1999, I HAD 2 BAK CAGES PUT IN MY L5S1 AREA, FOR 3 MOS I WAS GOOD, THEN IT ALL CAME BACK. ALL CT, MRI'S SHOWED I HAD FUSED. A DISCOGRAM WAS DONE. I HAD A FAILED FUSION; A REVISION WAS NEEDED. IN 2005 ONE WAS DONE AND THAT FAILED. SINCE THESE SURGERIES, I HAD 0 FLEXION LIMITED MOTION AND CONSTANT PAIN. I TRIED TO HAVE THEM REMOVED. I WAS TOLD BY A SURGEON, THEY CANNOT. THE BLOOD VESSELS "BBB" CLING TO THE TITANIUM. I ALSO HAVE LEG PAIN, CANNOT SIT, STAND OR WALK FOR LONG PERIODS SINCE MY SURGERY. SOMETHING IS NOT RIGHT. I DIDN'T HAVE ALL OF THIS BEFORE MY FUSION. IT STARTED AFTER THE SURGERY. THESE CAGES NEED TO BE FURTHER INVESTIGATED TO THE MAX. I WILL HAVE TO LIVE WITH CONSTANT PAIN, CONSTANT LOSS OF MOBILITY, IT REALLY HAS CHANGED MY LIFE. IT HAS TAKEN YRS FOR ME TO ACCEPT THIS. IF I KNEW THEN WHAT I KNOW NOW, I WOULD HAVE NEVER HAD A FUSION. I ALSO HAD LUCENCY OF MY CAGES AND NOW DUE TO A FAILED REVISION, A FAILED FUSION I'M STUCK WITH ALL THIS HARDWARE AND STUCK WITH PAIN.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM REPORTER ON 04/10/2014: LEFT THIGH SWOLLEN NUMBNESS, NERVE PROBLEMS. LEFT THIGH STILL SWOLLEN FUSION FAILED REQUIRED REVISION- 2005 REVISION FAILED- DIAGNOSED DEGENERATIVE DISC DISEASE. THE REMAINDER OF THE DISC SHATTERED. IN 1999 A FUSION WAS PERFORMED. I WOKE UP IN THE HOSPITAL LEFT THIGH SWOLLEN, NUMBNESS - 3 MONTHS I DID START FEELING BETTER WHEN OUT WALKING A SHARP PAIN SHOT ACROSS MY BACK IT MADE A SOUND AND DOWN MY LEFT LEG. TEST SHOWED I HAD FUSED AT LEAST THE CT MYELOGRAM IT TOOK ME TO 2005 TO FIND A DOCTOR TO EVEN LOOK AT MY MEDICAL. HE DID A DISCO SRAM, NO I DID NOT FUSE. HE DID A REVISION IN 2005 THAT DID NOT FUSE. I LIVE EVERY HOUR IN CHRONIC PAIN AND NOW THE CAGES CAN'T BE TAKEN OUT I WANT THEM OUT IN 2005 THE DOCTOR SAID THEY CAN'T. THROUGH MRI, CT SCANS, X-RAYS, DISCO SRAM, NERVE CONDITION TEST. THIS FUSION HAS RESTRICTED MY MOBILITY, FLEXION BACK, SIT, STAND, WALK LIMITED. I WIL HAVE NOTHING BUT A LIFE OF CHRONIC MISERABLE PAIN. I ASSUMED MY DOCTOR WOULD HAVE REPORTED THIS; APPARENTLY NOT. I WAS ON NARCOTICS FOR 13 YEARS. I STOPPED TAKING THEM. I SOAK IN HOT WATER. I TAKE IBUPROFEN, ALEVE ON A DAILY BASIS AND AT NIGHT TWO TYLENOL PAIN RELIEVER NITETIME SLEEP AIDES. I AWAKEN BETWEEN 2 AM AND 3 AM WITH MY LUMBAR IN PAIN. THESE FUSIONS ARE NOT FOR EVERYONE. I HAVE DEGENERATIVE DISC DISEASE WAS TOLD THE FUSION WOULD HELP, WELL IT DIDN'T. IMPLANT WAS PUT IN (B)(6) 1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176419 BAK TITANIUM CAGE CAGE MAX
    176420 BAK TITANIUM CAGE CAGE MAX

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other