MAUDE Adverse Event Report: NTI CLENCHING SUPPRESSION SYSTEMNTI SPLINTNOCICEPTIVE TRIGEMINAL INHIBITION REFLEX DEVICE

Event Type  Injury   Patient Outcome  Other,Required Intervention

Event Description

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.

• Brand Name: NTI SPLINT
• Type of Device: NOCICEPTIVE TRIGEMINAL INHIBITION REFLEX DEVICE
• Manufacturer (Section F): NTI CLENCHING SUPPRESSION SYSTEM; *
• Manufacturer (Section D): NTI CLENCHING SUPPRESSION SYSTEM; *
• Device Event Key: 459858
• MDR Report Key: 471018
• Event Key: 446429
• Report Number: MW1028944
• Device Sequence Number: 1
• Product Code: LQZ
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/03/2003

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 07/03/2003
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: Health Professional
• OTHER Device ID Number: WWW NTI-TSS.COM.CONSENTIBTOR
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: Yes
• Event Location: Unknown
• Was The Report Sent To Manufacturer?: No
• Is the Device an Implant?: No
• Is this an Explanted Device?: No Answer Provided