MAUDE MDR 3493714

MDR report key
3493714
Report number
MW5033121
Event key
0
Event type
3
Date of event
2013-10-21
Date received
2013-11-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NTI TSS 2.0 BITE GUARDNTI TSS 2.0 BITE GUARDNTI-TSS INCOCO

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-11-2501. L; 2. R

Event Narratives#

D

Patient 1

MY DENTIST,(B)(6), INSTRUCTED ME TO WEAR AN NTI-TSS BITE-GUARD FOR ALLEGED NIGHT-TIME BRUXISM. SHE CITED RECEDING GUMS AND WEAR TO MY TOOTH SURFACES. SHE SOLD IT TO ME IN (B)(6) 2010. I WAS NEVER GIVEN AN INFORMED CONSENT TO SIGN, DID NOT KNOW THE RISKS OF THE DEVICE, NOR OF THE EXISTENCE OF ANY INFORMED CONSENT WAIVER. AFTER ABOUT 7 MONTHS OF WEARING IT NIGHTLY, I AWOKE ONE NIGHT TO FIND IT MISSING FROM MY MOUTH. I FOUND IT, SPLIT IN TWO, RESTING ON THE NIGHTSTAND. I COULD HAVE EASILY CHOKED TO DEATH ON IT IN MY SLEEP. I REPORTED IT TO MY DENTIST, WHO SAID I STILL NEEDED A BITE-GUARD AND SHE WOULD MAKE ME A THICKER, WIDER ONE, STILL AN NTI. I TRUSTED HER AND OBEYED. OVER TIME, I BEGAN TO NOTICE THAT MY TEETH HAD BEGUN TO FEEL LIKE THEY DID NOT FIT PROPERLY TOGETHER. I STARTED TO HAVE DIFFICULTY TEARING AND CHEWING MY FOOD. MY FRONT INCISORS GRADUALLY MOVED SUCH THAT THEY NO LONGER MEET UNLESS I CROSS MY BITE. I WENT TO MY DENTIST, DOCTOR (B)(6) IN (B)(6) 2013 (DOCTOR (B)(6) RETIRED (B)(6) 2013 AND (B)(6) BOUGHT HER PRACTICE). I ASKED THE DENTIST, "HAS MY BITE CHANGED? IT FEELS LIKE IT HAS. I CAN'T TEAR THINGS." DOCTOR (B)(6) SAID HE WOULD LOOK IN MY RECORD AND ASKED HIS ASSISTANT IF THERE WAS ANY EVIDENCE OF HISTORY OF "ANTERIOR OPEN BITE." I WENT HOME, (B)(6) THIS AND NTI AND FOUND THAT THERE HAS BEEN COMPLAINTS ABOUT THIS PROBLEM AND AT LEAST ONE LAWSUIT. I AM NOW FACED WITH HAVING TO SPEND (B)(6) ON CORRECTIVE BRACES FOR 18-20 MONTHS, TO MAKE MY TEETH MEET AGAIN SO I MAY RETURN TO EATING NORMALLY. I ALREADY HAD BRACES AND HEADGEAR FOR 1.5 YEAR IN 1996, AS A TEENAGER. THEREFORE, THIS APPLIANCE HAS DESTROYED WHAT MY FAMILY SPENT (B)(6) FOR IN 1996. THIS NOW NECESSARY TREATMENT PLAN IS NOT AFFORDABLE, NOR CONVENIENT. FURTHERMORE, I STILL WILL NEED TO PURCHASE A TRADITIONAL NIGHT-TIME BITEGUARD BECAUSE AS FAR AS I KNOW, BRUXISM IS AN ONGOING ISSUE FOR ME, AND THAT COSTS (B)(6). ULTIMATELY THIS NTI WILL HAVE COST ME AT LEAST (B)(6) IN CORRECTIVE PROCEDURES AND WASTED MONEY.