MAUDE MDR 8439811

MDR report key
8439811
Report number
MW5085062
Event key
0
Event type
3
Date of event
2018-12-17
Date received
2019-03-20
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0IPS EMPRESS DIRECT COMPOSITEPOWDER, PORCELAINIVOCLAR VIVADENT AGEIHI *
1IPS EMPRESS DIRECT COMPOSITEPOWDER, PORCELAINIVOCLAR VIVODENT AGEIHI *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-2001. O; 2. R

Event Narratives#

D

Patient 1

REQUIRED REMOVAL OF FLAWED PRODUCT AND REPLACEMENT WITH NEW, WHICH WAS CHARGED AS A NEW PROCEDURE BY MY DENTIST. LESS THAN 3 YRS AGO, MY DENTIST APPLIED / INSTALLED SEVERAL "FILLINGS" TO THE FRONT SURFACES OF SOME OF MY TEETH USING IPS EMPRESS DIRECT COMPOSITE DENTAL FILLING MATERIAL. I HAD NEVER HAD ANY PROCEDURE LIKE THIS DONE BEFORE, SO I DIDN'T KNOW WHAT TO EXPECT. I HAD PREVIOUSLY HAD COMPOSITE FILLINGS THAT REPLACED AMALGAM FILLINGS IN MOLARS, AND BOTH THE AMALGAM FILLINGS AND THE REPLACEMENT COMPOSITE FILLINGS HAVE LASTED MANY YEARS, AND THEY ARE ALL STILL INTACT AS FAR AS I RECALL. IN (B)(6) 2018, I NOTICED A VERY ODD TEXTURE ON THE FRONT SURFACE OF ONE OF THE TREATED TEETH. IT WAS JUST BEFORE THE (B)(6) HOLIDAYS, BUT I WAS ABLE TO BE SEEN BY MY DENTIST. HE INFORMED ME THAT THE FILLING MATERIAL HAD COME OFF. I SAID I DIDN'T RECALL EATING / DRINKING ANYTHING THAT WOULD CAUSE THIS, AND HE CONFIRMED THAT THIS JUST SOMETIMES HAPPENS AND I SHOULD NOT FEEL RESPONSIBLE. I WAS ABLE TO GET AN APPT WITH MY DENTIST ON (B)(6) 2019. I SUBSEQUENTLY CALLED MY DENTIST'S OFFICE FOR THE NAME OF THE COMPOSITE USED BECAUSE AFTER REPLACEMENT I DECIDED I WANTED TO RESEARCH THE LONGEVITY OF THE FILLING MATERIAL. THEY TOLD ME IT WAS IPS EMPRESS DIRECT COMPOSITE MATERIAL. I READ ONLINE INFO ABOUT THIS PRODUCT AND COULD NOT FIND ANY REFERENCE TO EXPECTED DURABILITY / LONGEVITY, BUT I BELIEVE IT IS SUBSTANDARD FOR AN ANTERIOR FILLING TO LAST LESS THAN 3 YEARS. I DO NOT ROUTINELY EAT HARD, CRUNCHY FOODS NOR DO I CHEW ON BONES, SO I DO NOT BELIEVE I DID ANYTHING TO CAUSE THIS PROBLEM.