NTI TSS 2.0 BITE GUARD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-25 for NTI TSS 2.0 BITE GUARD manufactured by Nti-tss Inc.

Event Text Entries

[4152958] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5033121
• MDR Report Key: 3493714
• Date Received: 2013-11-25
• Date of Report: 2013-11-23
• Date of Event: 2013-10-21
• Date Added to Maude: 2013-12-02
• 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: 0
• Reporter Occupation: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NTI TSS 2.0 BITE GUARD
• Generic Name: NTI TSS 2.0 BITE GUARD
• Product Code: OCO
• Date Received: 2013-11-25
• Operator: LAY USER/PATIENT
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NTI-TSS INC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Required No Informationntervention	2013-11-25