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Event Type  Injury  
Event Description

Upon the advice of my former physician, dr, i had the charite artificial disk implanted in my spine in 2005. This implant is located in the lumbar region, at l4-l5. I was in severe, unrelenting pain after the surgery, not just in my lower back but in my hips, buttocks, legs and feet. I found out this was due to the inflammation of the sciatic nerve. In the weeks and months following the surgery, this back and leg pain continued unabated, even with the assistance of a pain mgmt physician. Problem: i began physical therapy several months after the surgery, and according to my physical therapist, i was not progressing, i could barely perform the most basic stretching exercises and was in terrible pain if she attempted an exercise routine. The lack of progress in my recovery and the continued pain was of great concern to me, so i made an appointment to see dr in approx five months later. At this time, nearly five months after the surgery, i was spending more than half my day in bed because of the pain. In addition, i couldn't bend, which seemed very strange considering this was supposed to be the great benefit of the charite artificial disk. Dr took x-rays of my back, and upon review he became agitated and nervous. He proceeded to tell me that everything was fine with my back, and when i protested that i was having a very difficult recovery, he grew extremely hostile, angry and defensive. He was unwilling to run more tests, although i pressured him into agreeing to take an mri. (the mri was never taken-his office staff needed to call for insurance approval, which they never did. They also never followed up with me. ) product error: feeling extremely unhappy about the treatment i received from dr. I sought a second opinion. In the same month, my second physician took new x-rays. He compared these with the x-rays taken during the disk replacement surgery on original date. I was subsequently told that the charite artificial disk had moved out of place, even though i was assured prior to surgery this could not happen, and that the severe pain i was experiencing was because of the spinal misalignment. As a result, i had developed scoliosis of the spine, and my left hip was higher than my right, which was causing me to constantly trip. In addition, dr felt my sciatic nerve had been stretched during the artificial disk surgery, which explained the brutal, unrelenting pain in my hips, buttocks, legs and feet. Dr explained that the height of the charitie artificial disk is greater than that of a normal human disk, and that the sciatic nerve is very sensitive to being stretched. Thus, even with pain management, my leg and back pain was completely out of control, profoundly worse than prior to the artificial disk implantation. Upon review of all the date, it became clear a decision had to be made, i could either have the artificial disk removed, knowing that some twenty percent of patients who choose this path will die during the procedure, or have a posterior fusion to immobilize the artificial disk and keep in my spine. Even knowing the risks, i very much wanted to have the artificial disk removed, but dr was not comfortable with this decision. Instead, in 2006, he performed a posterior fusion at l4-l5, immobilizing the spine in this region and keeping in the artificial disk. And while future damage of the spine is being prevented, i am still dealing with the ramifications of the damage the artificial disk did cause. I am told the sciatic nerve that was stretched out by the artificial disk placement may or may not calm down at some point in the future. In the meantime, i must have selective nerve root blocks every four to six weeks in an operating room at a local hosp. These injections consist of steroid shots directly into the sciatic nerve as it exits the spine at l4-5. Because of all the scar tissue and the fusion in my back, the needles to get to my spine have to enter close to my hips and go through all my back muscles. As may be imagined, the needles are extremely long and very painful. The injections and recovery are not only painful, but very expensive. In terms of pain management, my future is very unclear. Dr has said, he can remove the screws from the l4-l5 fusion to see if this will provide some relief from the unrelenting pain. However, he has stated that he really doesn't favor the surgery, as it is completely ineffective in fifty percent of the cases, and for the remaining fifty percent, the rate of pain relief ranges from slight to only somewhat effective. In the meantime, the fentanyl narcotic patch i must wear at all times is the maximum dosage allowed by my pain clinic (100mg/hr). The fentanyl patch only takes the edge off my pain, so i must take additional oral narcotics (tramadol) throughout the day. In order to sleep at night, i must take a muscle relaxant, and even then wake up frequently and sometimes take more narcotics. I am so tired all the time from this medicine that i must constantly drink caffeine all day long just to stay awake. I have tried both traditional and alternative therapies to try and alleviate the pain caused by the artificial disk. I have been through months of physical therapy and massage, have tried acupuncture and alternative medicine. Nothing alleviates the long term pain. I continue to exercise at home, and while i now have very strong core muscles, the back pain is still just as intense. As a direct result of the damage and pain caused by the charite artificial disk, i am unable to have a normal, physical marital relationship with my husband. This has put a huge strain on my marriage. In addition, i have two small children and a household that i need to take care of, which is an enormous everyday struggle. Since the disk replacement surgery, i have lost nearly fifty pounds, so for my height this is underweight. I have to spend most of my meals standing in the kitchen, as it hurts to sit down. And if i eat too much at any one time, the food in my abdomen presses on my spine where the artificial disk is in place, which causes me horrific pain until the food is digested. As a result of this rapid weight loss, i have developed anemia. I am unable to return to work opportunity. This is a job that i love, that i had spent close to fifteen yrs of my life dedicated to prior to the artificial disk surgery. And whereas i used to travel internationally for several weeks at a time, now i can barely travel to another suburb. In short, every single aspect of my life has been detrimentally altered as a direct result of the charite artificial disk, and i face an uncertain future of constand pain.

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Manufacturer (Section D)
raynham MA
MDR Report Key889468
Report NumberMW5003275
Device Sequence Number1
Product CodeMJO
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/02/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Is this a Reprocessed and Reused Single-Use Device? No

Date Received: 08/02/2007 Patient Sequence Number: 1