FDA.reportPublic FDA data

MAUDE MDR 6205082

MDR report key
6205082
Report number
3005174370-2016-00157
Event key
0
Event type
3
Date of event
2015-03-02
Date received
2016-12-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ANGIE DRAPER
Address
2510 CONWAY AVENUE ST. PAUL MN 55144 US
Phone
651-651-6517
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RELYX LUTING LUTING CEMENTDENTAL CEMENT3M ESPE DENTAL PRODUCTSEMA3505R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-12-2701. R

Event Narratives#

N

Patient 1

SINCE THERE WERE TWO MEDICAL DEVICES INVOLVED IN THIS EVENT, TWO MANUFACTURER REPORTS ARE BEING SUBMITTED. THIS REPORT CONTAINS INFORMATION ABOUT THE SECOND DEVICE. MANUFACTURER REPORT 300517-2016-00156 CONTAINS INFORMATION ABOUT THE FIRST DEVICE. BASED ON THE AVAILABLE INFORMATION, IT IS NOT KNOWN WHAT ROLE, IF ANY, THE RELYX LUTING CEMENT PLAYED IN THIS REPORTED OUTCOME. OTHER FACTORS, SUCH AS PRIOR TOOTH HISTORY AND DENTAL TREATMENTS, MAY HAVE PLAYED A ROLE IN THE NEED FOR THE ROOT CANAL. MOREOVER, THE RELYX LUTING CEMENT WAS MISUSED IN THIS APPLICATION, AS IT IS NOT INDICATED FOR USE WITH INDIRECT COMPOSITE RESTORATIONS.

D

Patient 1

ON (B)(6) 2016, A DENTAL PROFESSIONAL REPORTED THE CASE OF A PATIENT (AGE AND GENDER NOT PROVIDED) WHO REQUIRED ROOT CANAL THERAPY ON TOOTH #19. THIS TOOTH HAD RECEIVED A 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D CROWN ON (B)(6) 2014, ON A TOOTH WHICH HAD A PRIOR RESTORATION AND DECAY BENEATH IT. THE CROWN WAS SECURED WITH A NON-RECOMMENDED CEMENT TYPE, 3M ESPE RELYX LUTING CEMENT. IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT REQUIRED ROOT CANAL THERAPY AND REPLACEMENT OF THE CROWN.