NTI-TSS-PLUS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-27 for NTI-TSS-PLUS manufactured by Boyd Research Inc..

Event Text Entries

[25002126] My dentist sold me a mouth / jaw device) that was supposed to ease headaches; well, it broke my tooth; front left inside. It hurts and i am constantly fearful of my partially broken tooth-totally falling apart now. Every time i eat, etc. , the worst part is when i told the dentist, he refused to take any responsibility for it nor, would he give me the same/address of his insurance company so i can file a small claim. The device, which acted like a hard piece candy, cost-ed (b)(6) - i'm still paying for it. However, my last visit, he offered to "fix it" for (b)(6)- hindsight tells me that he was more interested in making a sale, an extra (b)(6). Anyone with a history of grinding, etc which is how it's sold has headaches, but also potentially weakened teeth. My teeth were not perfect, but i had a great smile. Not anymore. This device, sold to me as a miracle that will "slide and glide" no, it is more like putting a jaw-breaker in your mouth. Especially at night? Perhaps a work stimulus program if it happens to someone insured they just get a new front tooth ordered up by the smiling dentist; that recourse do i have now? I only used this device a total of 6 times, during the day for a few minutes and then i tried it twice at night- it happened the second time, i bit down hard and the natural veneer of my front tooth just shattered; i woke up, choking with small, sharp pieces in my mouth. I am very upset. This device is called the "nti-tss plus". The headacheremedy. Com i could find no way to contact them but they sell this device as "made of safe, clear, hard, thermo-plastic material, i still have the brochure. There is no way to not bite down hard on the little hard device. I have no money for an attorney, much less a new front tooth. I had headaches, sure, but now i have no peace of mind. I've lost health, wealth, and peace of mind. I wish i had never heard this guy's smooth "pitch" they sure teach them to act concerned and make the safe; but not much more than that except evasive maneuvers, refusal to take responsibility later. How many have broken a tooth, like me, uninsured, with no recourse? How many have merely enjoyed their insurance plan replacing a tooth broken this way? Thank you. The last visit, (b)(6) 2015, when i showed the dentist the damage, he agreed i needed a new tooth now, but that i'd have to pay for it and he gave me a summary of potential charges trying to get me to put more on the "care credit" service for an extra (b)(6). I use crutches for a recent knee injury - when my knee starts to "give out" or my new cane. I have a small glass of port at night to ease pain and help relax me, enthusiastically encouraged by my chiropractor. I eat a healthy, fresh, mostly organic diet with no junk foods or sodas; because processed corn is hidden in so many ways, i have no avoid most processed foods. I'm a cook/nutritionist, i exercise mildly, i am in great shape, except for a recent injury to my right knee and now a broken front tooth which is affecting my ability to even just eat.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5055879
MDR Report Key5049245
Date Received2015-08-27
Date of Report2015-08-27
Date of Event2015-02-16
Date Added to Maude2015-09-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameNTI-TSS-PLUS
Generic NameNTI-TSS-PLUS
Product CodeOCO
Date Received2015-08-27
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBOYD RESEARCH INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2015-08-27

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