MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-18 for LVI GLOBAL "FIXED" ORTHOTIC NO MODEL DOES NOT EXIST manufactured by Unk.
[167399335]
After 2 dental malpractices, i was referred to see an lvi global "expert". I was told that he would find my physiological bite using a tens unit, myo-machine, and then a "fixed orthotic". The "fixed orthotic" is like a huge bite guard, but adhered to the entire arch of the bottom teeth. It is not removeable except by an lvi global dentist. This was to find the bite and stabilize my jw relieving the tmj / tmd. It failed and caused issues. He ripped it off, then put it on again. Again, it failed and i had worse pain, he ripped it off again and adhered it on my teeth a third time, which failed. The pain was unbelievable. He wanted to do it again, but i refused because this was pain i never felt in my life. I went to the emergency room (er), the sent to neurology where i was diagnosed with trigeminal neuralgia. The pain never dissipated, but got worse. I then was diagnosed with occipital neuralgia as well. The dentist said there is no such thing and said it was just tmj and a calcified tendon. He was wrong. I went out of state where an implant expert cleaned out my implant and the pain was down 70% but he said i probably had a hairline jaw fracture due to the ripping off of the "fix orthotic" and that my jaw was also spasming because the "fixed orthotic" had elevated my bite way too much. He said he never even saw or knew what a "fixerd orthotic" was. And laughed when i showed him pictures. He said it was malpractice and too call a lawyer. I have found victims such as myself that this lvi global worked on. It seems they look for tmj pts who have had other work done, promise a "proven" method works and then destroys our mouths pushing a (b)(6) full mouth restoration. They cal us the "money joint" people. I since have found that this is not an accepted form of treatment in either dental or medical, but they keep doing it to people. I got shingles from stress, had a nervous breakdown, several infections, still cannot eat solid food, had acrylic or whatever material it was breaking off in the middle of the night and swallowing it. It was just a huge mess. No one else uses this device, and only certain labs are contracted out by lvi global in order to make them. I did not know any of this despite the fact that i asked all the right questions. My lvi dds just outright lied to me. I asked for a refund of the (b)(6) he charged me, he sent me a box of teeth, mold and garbage instead via (b)(6) with a letter stating that my case was finished and no refund. I have had 4 root canals on teeth he killed, and have several medical / dental issues due to this. Also, when i asked for treatment plan to submit to insurance, he kept avoiding it, and had his office apply for loans using my protected info, he stole everything from me and left me with no teeth, and a whole hoist of pain. This devic needs to be banned and lvi global needs to stop what they are doing and pay to have real treatment done for its victims. I had a lot of tests. He tortured me for 8 months with this thing. I had an er visit for tis, ct scans, mri, cone beam scans, x-rays, blood work, more urgent care visits, several dental visits out of state with more fancy full lead x-rays the list goes on. I asked for all my records from the dds and the office only sent me falsified treatment notes, that is all. I had to file 2 hipaa complaints to get that. I have 3 versions of the same treatment, but they are all different. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[184516837]
Add'l info received from reporter on 03/16/2020 for report mw5091171: dds lied and was fraudulent. Said his treatment was proven, later to find out, i was being experimented on with a "fixed" orthotic and tens units/computers. He changed his explanations many times, and gas lighted and intimidated me into "not complaining because i would dismiss you" and i would have nowhere else to go. This treatment is not recognized as a standard dental care and i was not allowed, informed consent due to his lying. He molded my teeth, sent it to (b)(6) lab, then adhered a big orthotic onto my lower teeth. I could not take it off. It caused jaw issues and pain among other things. He drilled and ripped it off and put it on again. I had worse pain. He drilled the upper teeth and put giant temp crowns on them where i could not close my mouth. I had even more issues. He said the tens unit and computer were going to give me my perfect physiological position, but it did not. He drilled and ripped off the orthotic again, and put it back on a 3rd time. I then ended up in the er and then neurologist. I was diagnosed with trigeminal neuralgia. My dds said there was no such thing and to just take a tylenol and advil. I told him my pcp did not want me to take those, but he still told me to. (i did not) ended up on anti-seizure meds, and now a muscle relaxer. I have chipped rotting teeth under plastic temps, drilled own metal in my mouth, several infections, cannot chew, and lots of pain. I went in so i could eat, speak, sing, and be out of pain, and this treatment made everything 1000 times worse. This fixed orthotic is something that only (b)(6) and "neuromuscular ddss" know about but no pts are ever aware. I asked all the right questions but was lied to. I have been working with the nasem on this and was happy about their report. (b)(6) there is illegal stuff going on in the dental industry. The ada knows, but i also know their lobby efforts. This treatment and institute needs to be shut down. It is hurting a lot of people, but nobody knows due to the laws passed that makes dental malpractice impossible to try. These fixed orthotics are made in (b)(6) sponsored labs, so if i am not mistaken, this is also an ftc anti-trust violation as well. Since these ddss are obtaining temp licenses to take classes in order to advertise as specialists where there is no specialty. This is going on world wide. People from other countries are flying into (b)(6) to learn to do this to people and going back to home states / countries and harming many. Please help, stop this and protect the public. I had x-rays that they will not give me. A cbct that they will not give me. And they will not give me life. I have already filed 2 hipaa violations, but they still wont give them to me. I also had at the er for stroke, heart, and mri and ct for the trigeminal neuralgia. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5091171 |
| MDR Report Key | 9342729 |
| Date Received | 2019-11-18 |
| Date of Report | 2019-11-14 |
| Date of Event | 2018-10-03 |
| Date Added to Maude | 2019-11-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LVI GLOBAL "FIXED" ORTHOTIC |
| Generic Name | PROSTHESIS, ORTHODONTIC |
| Product Code | NSR |
| Date Received | 2019-11-18 |
| Model Number | NO MODEL |
| Catalog Number | DOES NOT EXIST |
| Lot Number | IT'S A MADE UP DEVICE |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2019-11-18 |