NTI SPLINT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-03 for NTI SPLINT * manufactured by Nti Clenching Suppression System.

Event Text Entries

[322667] This device will reposition the condylar, it will not stop migraines, it took out pt's two front crown teeth, it causes tooth movement, joint strain, and that all pts should be made aware of the contra-indications for it. In 08/2001, nti took out the pt's 2 front teeth. They had paid over $10,000. 00 to fix their mouth and pt is still in pain. This device is harmful - dangerous and it is not therapeutic. Pt had to have surgery to undo the harm that was caused by the nti splint.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1028944
• MDR Report Key: 471018
• Date Received: 2003-07-03
• Date of Report: 2003-07-03
• Date Added to Maude: 2003-07-14
• 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: 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 SPLINT
• Generic Name: NOCICEPTIVE TRIGEMINAL INHIBITION REFLEX DEVICE
• Product Code: LQZ
• Date Received: 2003-07-03
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: WWW NTI-TSS.COM.CONSENTIBTOR
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 459858
• Manufacturer: NTI CLENCHING SUPPRESSION SYSTEM
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2003-07-03