MAUDE MDR 1334370

MDR report key
1334370
Report number
MW5010174
Event key
0
Event type
3
Date of event
2009-01-13
Date received
2009-03-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1HELIOMOLAR CAVIFILDENTAL FILLING MATEIRALIVOCLAR VIVADENT, INC.EBD N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-03-0301. O

Event Narratives#

D

Patient 1

DENTIST ADVISED THAT -2- VERY OLD FILLINGS, ON -2- UPPER BACK MOLARS SHOULD BE REPLACED. MY MOLARS DID NOT HAVE PAIN, SENSITIVITY, CRACKS OR ANYTHING WRONG WITH THEM. BY EARLY 2009, RETURNED TO DENTIST WITH PAIN, SENSITIVITY COMING FROM THE FILLED TEETH. SENSITIVITY WAS CONFIRMED, ADDITIONAL X-RAYS TAKEN, WITH NO VISIBLE SIGNS OF ANY CRACKS IN THE TEETH. REFERRED TO ENDODONTIST. ACUTE SENSITIVITY DETECTED AND ROOT CANAL PERFORMED ON ONE OF THE MOLARS. NO CRACKS WERE SEEN IN ANY OF THE DENTAL XRAYS AND AN EXPLANATION COULD NOT BE GIVEN FOR WHAT HAPPENED. THE SECOND MOLAR, A WISDOM TOOTH HAD THE SAME PROBLEM. INSTEAD OF A ROOT CANAL, OPTED TO HAVE IT EXTRACTED. CHECKED WITH THE DENTIST ON FILLING MATERIAL USED SO, I COULD FIND AN EXPLANATION FOR MYSELF. THE NAME OF THE PRODUCT IS HELIOMOLAR HB, CAVIFIL, DENTAL COMPOSITE FILLING MATERIAL. THE DENTIST CONTACTED THE MANUFACTURER AND FOUND NO INGREDIENTS HAD CHANGED. I LOOKED UP ANY ADVERSE REACTIONS BUT FOUND NONE, JUST AN ISSUE WITH ANOTHER PRODUCT BY THIS MANUFACTURE, BUT NOT THE CAVIFIL. I THOUGHT I WOULD REPORT THIS BECAUSE I CANNOT FIND ANOTHER REASON FOR WHAT HAPPENED TO MY MOLARS. HAD TO GO THROUGH MANY PAIN PILLS, INFLAMMATORY MEDICINES AND TWO DOSES OF ANTIBIOTICS SINCE I HAD TO BE PUT ON A STRONGER ONE THROUGH THIS WHOLE ORDEAL. I WOULD LIKE TO KNOW IF THERE ARE ANY OTHER COMPLAINTS ABOUT THIS PRODUCT SO, I KNOW WHAT TO DO NEXT TIME I NEED A FILLING REPLACED. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: DENTAL FILLING MATERIAL USED ON MOLARS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.