RELYX ULTIMATE ADHESIVE RESIN CEMENT
Received Oct 8, 2015 · Event occurred Oct 17, 2013
Report 9611385-2015-00039 · MDR key 5136161
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
43 YR
- No Code Available
Narrative
Additional Manufacturer Narrative
SINCE THIS EVENT INVOLVED TWO MEDICAL DEVICES, TWO MANUFACTURER REPORTS ARE BEING SUBMITTED. MANUFACTURER REPORT NUMBER 3005174370-2015-00073 DESCRIBES THE FIRST DEVICE.
Description of Event or Problem
ON SEPTEMBER 9, 2015, A REPRESENTATIVE FROM A DENTAL OFFICE REPORTED THAT A PATIENT WHO HAD A CROWN MADE FROM 3M ESPE LAVA ULTIMATE IMPLANT CROWN RESTORATIVE, REQUIRED A ROOT CANAL. THIS CROWN WAS SEATED ON (B)(6) 2013, USING 3M ESPE RELYX ULTIMATE ADHESIVE RESIN CEMENT. SENSITIVITY WAS NOTED WHILE THE CROWN WAS BEING SEATED AND BY (B)(6) 2013, IT HAD WORSENED; A ROOT CANAL WAS RECOMMENDED AND WAS PERFORMED ON (B)(6) 2013. AFTER THE ROOT CANAL, THE PATIENT REMAINED SENSITIVE, SO A SECOND ROOT CANAL WAS DONE ON (B)(6) 2013. AT THE CURRENT TIME, THE TOOTH IS REPORTED TO BE FEELING BETTER.