RELYX ULTIMATE ADHESIVE RESIN CEMENT
Received Dec 10, 2015
Report 9611385-2015-00108 · MDR key 5287418
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Code Available
Narrative
Additional Manufacturer Narrative
SINCE THIS EVENT INVOLVED FOUR MEDICAL DEVICES, FOUR MANUFACTURER REPORTS ARE BEING SUBMITTED. THIS REPORT DESCRIBES THE THIRD DEVICE. MANUFACTURER REPORT NUMBERS 3005174370-2015-00126, 9611385-2015-00107, AND 9611385-2015-00109 DESCRIBE THE FIRST, SECOND, AND FOURTH DEVICE, RESPECTIVELY.
Description of Event or Problem
ON (B)(6) 2015, A DENTAL ASSISTANT REPORTED ONE PATIENT WHO REQUIRED A TOOTH EXTRACTION. THE PATIENT HAD A RESTORATION MADE FROM 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC WHICH WAS SECURED WITH 3M ESPE RELYX ULTIMATE ADHESIVE RESIN CEMENT, RELYX UNIVCEM 2 CEMENT AND SCOTCHBOND UNIVERSAL ADHESIVE. ON (B)(6) 2015, IT WAS REPORTED THAT THE DOCTOR WAS NOT 100% SURE THAT THE EXTRACTION WAS DUE TO THE CROWN BECAUSE THERE WERE OTHER FACTORS INVOLVED.