FDA Adverse Event Injury Summary report: N

NTI-TSS

MDR report key: 1850007 · Received September 28, 2010

Report

Report Number
MW5017614
Event Type
Injury
Date Received
September 28, 2010
Report Date
September 3, 2010
Manufacturer
NTI-TSS, INC. (THE CHAIRSIDE SPLINT COMPANY, BIO RESEARCH ASSOCIATES, INC.; ACTU
Product Code
OCO
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

NTI-TSS DEVICE, OVER A PERIOD OF MANY MONTHS CAUSES THE TEETH BEHIND IT TO DROP INTO THE GAP THAT IS MADE BY THE DEVICE. FOLLOWING PROLONGED USE, THE DEVICE USER WILL BE UNABLE TO CLOSE THEIR MOUTH (PUT TEETH TOGETHER), NOR CHEW FOOD PROPERLY, SPEAK PROPERLY OR SLEEP. ALSO, TEMPOROMANDIBULAR JOINT DYSFUNCTION IS MADE WORSE BY THE DEVICE BECAUSE IT CAUSES UNEVEN PRESSURE TO BE APPLIED TO THE TEETH AND PLACES THE TMJ UNDER INCREASED STRESS. THE DROP-DOWN EFFECT OF THE TEETH, CAUSED BY THE DEVICE, ALSO HAS THE SIDE-EFFECT OF THE TMJ, CAUSING PAIN IN THE ROOT AREA OF THE TEETH. NTI-TSS DEVICE DOES NOT STOP OR PREVENT BRUXISM/CLENCHING AND MAY NOT BE ABLE TO STOP OR PREVENT THE MUSCLES FROM "TRYING" TO GRIND TEETH. AFTER ABOUT ONE TO ONE AND A HALF YEARS OF USE, I WENT TO A (B)(6) ORO-FACIAL DENTAL CLINIC FOR DIAGNOSIS OF THE SYMPTOMS. IT WAS DETERMINED THAT THE DEVICE WAS CONTRIBUTING TO AND/OR CAUSING THE SYMPTOMS AND WAS TOLD TO DISCONTINUE USE OF IT. BECAUSE I HAD TWO VERSIONS OF THE DEVICE, ONE "STAND-ALONE" NTI-TSS FOR PRE-BRACES (WORN FOR ABOUT THREE TO SIX MONTHS) AND ONE INTEGRATED NTI-TSS/RETAINER FOR POST-BRACES (WORN FOR ABOUT ONE TO ONE AND ONE-HALF YEARS), I HAD TO DISCONTINUE USING BOTH WHICH MEANT THAT I HAD TO DISCONTINUE USING MY RETAINER, WHICH WAS ALSO CAUSED MY TEETH TO (BEGIN) RETURN (ING) TO THE WAY THEY WERE PRIOR TO THE BRACES. ALSO, THE MIGRAINES AND BRUXISM HAVE RETURNED AS THEY WERE PRIOR TO USE OF THE DEVICES. DATES OF USE: 1.5 TO 2 YEARS. DIAGNOSIS OR REASON FOR USE: BRUXISM/TMJD. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: YES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 NTI-TSS NTI-TSS OCO NTI-TSS, INC. (THE CHAIRSIDE SPLINT COMPANY, BIO RESEARCH ASSOCIATES, INC.; ACTU

Patients

Seq Age Sex Outcome Treatment
1 36 YR Required Intervention NTI-TSS