FDA Adverse Event Injury Summary report: N

NTI-TSS-PLUS

MDR report key: 5049245 · Received August 27, 2015

Report

Report Number
MW5055879
Event Type
Injury
Date Received
August 27, 2015
Date of Event
February 16, 2015
Report Date
August 27, 2015
Manufacturer
BOYD RESEARCH INC.
Product Code
OCO
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
570271 NTI-TSS-PLUS NTI-TSS-PLUS OCO BOYD RESEARCH INC.

Patients

Seq Age Sex Outcome Treatment
1 52 YR