NTI-TSS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-09-28 for NTI-TSS manufactured by Nti-tss, Inc. (the Chairside Splint Company, Bio Research Associates, Inc.; Actu.

Event Text Entries

[1431697] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5017614
MDR Report Key1850007
Date Received2010-09-28
Date of Report2010-09-03
Date Added to Maude2010-10-08
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameNTI-TSS
Generic NameNTI-TSS
Product CodeOCO
Date Received2010-09-28
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerNTI-TSS, INC. (THE CHAIRSIDE SPLINT COMPANY, BIO RESEARCH ASSOCIATES, INC.; ACTU


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2010-09-28

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