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U.S. Department of Health and Human Services

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

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NTI CLENCHING SUPPRESSION SYSTEM NTI SPLINT NOCICEPTIVE TRIGEMINAL INHIBITION REFLEX DEVICE   Back to Search Results
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.

 
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Brand NameNTI SPLINT
Type of DeviceNOCICEPTIVE TRIGEMINAL INHIBITION REFLEX DEVICE
Manufacturer (Section F)
NTI CLENCHING SUPPRESSION SYSTEM
*
Manufacturer (Section D)
NTI CLENCHING SUPPRESSION SYSTEM
*
Device Event Key459858
MDR Report Key471018
Event Key446429
Report NumberMW1028944
Device Sequence Number1
Product CodeLQZ
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 Received07/03/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
OTHER Device ID NumberWWW 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

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