NTI-TSS DENTAL DEVICE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-09 for NTI-TSS DENTAL DEVICE * manufactured by Keller Labs.

Event Text Entries

[21580439] Rptr was given a custom made "nti-tss" dental device by their dentist to help with bruxism. It was supposed to stop them from grinding. The nti-tss website states that this product works for everyone; their dentist said that they have used it with 100 pts with good results. Well, the result for rptr was that the device was not only ineffective but has done damage to their jaw alignment, bite, and facial appearance. The device caused them to grind their front teeth instead of their molars. Even though rptr only wore it for two weeks, rptr's jaw and their bite have not returned to "normal. " during the two weeks rptr wore it rptr suffered extreme headaches, facial pain, and their front teeth loosenned. Rptr has been back to their dentist numerous times but they don't understand why this has happenned and doesn't know what to do about it. Rptr's teeth are actually moving position since rptr can barely bite down without forcing their lower jaw back. Their front lower teeth are shifting back because they are constantly pushing against their upper teeth. Eating and chewing is challenging since they can't actually touch their upper and lower molars together without effort. Therefore, rptr's lower jaw spasms when they chew. The nti-tss website claims that there have been no claims against it. Rptr is not the only one harmed by this device. Please warn the public.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1033519
• MDR Report Key: 551955
• Date Received: 2004-09-09
• Date of Report: 2004-09-09
• Date of Event: 2004-06-25
• Date Added to Maude: 2004-10-29
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NTI-TSS DENTAL DEVICE
• Generic Name: DENTAL DEVICE TO STOP NIGHTTIME CLENCHING & GRINDING
• Product Code: LQZ
• Date Received: 2004-09-09
• Model Number: NA
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 541483
• Manufacturer: KELLER LABS
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2004-09-09