RELYX ULTIMATE ADHESIVE RESIN CEMENT
Received Sep 2, 2015
Report 9611385-2015-00021 · MDR key 5050537
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. MANUFACTURER REPORT NUMBER 3005174370-2015-00060 DESCRIBES THE FIRST DEVICE.
Description of Event or Problem
ON (B)(6) 2015, A DENTIST SHARED PATIENT RECORDS WHICH INDICATED A PATIENT REQUIRED EXTRACTION OF TOOTH #5. 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. PRIOR TO TREATMENT WITH THE LAVA ULTIMATE CROWN, THIS TOOTH, WHICH HAD A PFM CROWN, WAS NOTED AS HAVING DECAY PRESENT ON THE DISTAL MARGIN. THE TOOTH WAS RE-PREPPED AND THE LAVA ULTIMATE CROWN SEATED. ON (B)(6) 2014, THE PATIENT REPORTED THAT THE CROWN ON #5 FELT LOOSE. THE CROWN WAS REMOVED AND GROSS DECAY WAS PRESENT; THE PATIENT WAS RECOMMENDED TO HAVE THE TOOTH EXTRACTED. THE EXTRACTION WAS UNSUCCESSFUL DUE TO ANKYLOSIS AND THE PATIENT WAS REFERRED TO AN ORAL SURGEON.