MAUDE MDR 1306026

MDR report key
1306026
Report number
MW5009881
Event key
0
Event type
3
Date of event
2008-07-14
Date received
2009-02-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NTINIGHTGUARDNTILQZ Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-02-0401. S

Event Narratives#

D

Patient 1

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.