NTI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-02-04 for NTI manufactured by Nti.

Event Text Entries

[1006961] In 2006, i was prescribed an nti nightguard by my dentist, dr. Bob koenitzer, to help with gum recession due to bruxism. In 2007, i tell dr that "my bite is off" and he tells me that it is normal and no measurements are taken. I see him again for a cleaning approx three months later, and no measurements are taken or inquiry about my bite is made. I see him again for a cleaning four months later, and mention that my jaw is now hurting. Again, nothing about my treatment is checked in 2008, it is noted in my file that i am still wearing the nti device nightly. Four months later, i require an emergency exam because my jaw is in unbearable pain, and now when i put the nti device in, my molars in the back can now touch. My bite is now an open bite. I was in excruciating pain for 3 months, now have a speech impediment, am unable to eat in a normal way, and am at risk for losing my two top back molars due to the malocclusion. Dose or amount: na. Dates of use: 2006 - 2008. Diagnosis or reason for use: gum recession.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5009881
• MDR Report Key: 1306026
• Date Received: 2009-02-04
• Date of Report: 2009-02-04
• Date of Event: 2008-07-14
• Date Added to Maude: 2009-02-11
• 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: 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
• Generic Name: NIGHTGUARD
• Product Code: LQZ
• Date Received: 2009-02-04
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NTI

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2009-02-04