RELYX ULTIMATE ADHESIVE RESIN CEMENT
Received Sep 2, 2015
Report 9611385-2015-00022 · MDR key 5050559
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Code Available
Narrative
Additional Manufacturer Narrative
SINCE THIS EVENT INVOLVED TWO MEDICAL DEVICES, TWO MANUFACTURER REPORTS ARE BEING SUBMITTED. THIS REPORT DESCRIBES THE SECOND DEVICE. MANUFACTURER REPORT NUMBER 3005174370-2015-00061 DESCRIBES THE FIRST DEVICE.
Description of Event or Problem
ON (B)(6) 2015, A DENTIST SHARED PATIENT RECORDS WHICH INDICATED A PATIENT REQUIRED A ROOT CANAL ON TOOTH #14. THIS TOOTH HAD A CROWN MADE FROM 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC WHICH WAS SEATED ON (B)(6) 2013, USING 3M ESPE RELYX ULTIMATE CEMENT. THE PATIENT WAS SEEN ON (B)(6) 2014, REPORTING PAIN. AT THAT TIME, THE CROWN WAS REMOVED AND A ROOT CANAL PERFORMED. THE TOOTH WAS IMPRESSED AND TEMPORIZED; A PFM CROWN WAS USED AS REPLACEMENT.