InjuryEMA
RELYX ULTIMATE ADHESIVE RESIN CEMENT
Received Aug 16, 2016 · Event occurred Oct 14, 2015
Report 9611385-2016-00008 · MDR key 5878375
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
THIS EVENT INVOLVED TWO MEDICAL DEVICES, THEREFORE TWO MANUFACTURER REPORTS ARE BEING SUBMITTED. THIS REPORT DESCRIBES THE FIRST DEVICE. MANUFACTURER REPORT NUMBER 9611385-2016-00009 DESCRIBES THE SECOND DEVICE.
Description of Event or Problem
ON (B)(6) 2016, A DENTAL PROFESSIONAL INFORMED 3M ABOUT A PATIENT WHO REQUIRED ROOT CANAL. ON (B)(6) 2015, THE PATIENT HAD A PORCELAIN CROWN (NON-3M BRAND) SECURED WITH 3M ESPE RELYX ULTIMATE ADHESIVE RESIN CEMENT AND 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE. THE ROOT CANAL WAS PERFORMED ON (B)(6) 2015.