RELYX LUTING LUTING CEMENT
Received Dec 27, 2016 · Event occurred Mar 2, 2015
Report 3005174370-2016-00157 · MDR key 6205082
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
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.
Description of Event or Problem
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.