RELYX ULTIMATE ADHESIVE RESIN CEMENT
Received Oct 22, 2015 · Event occurred Sep 16, 2015
Report 9611385-2015-00049 · MDR key 5169436
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Code Available
Narrative
Additional Manufacturer Narrative
THIS EVENT INVOLVED TWO MEDICAL DEVICES, TWO MANUFACTURER REPORTS ARE BEING SUBMITTED. THIS REPORT DESCRIBES THE FIRST DEVICE. MANUFACTURER REPORT NUMBER 9611385-2015-00050 DESCRIBES THE SECOND DEVICE.
Description of Event or Problem
ON (B)(6) 2015, 3M WAS CONTACTED BY A DENTIST TO INQUIRE ABOUT PROPER USAGE OF TWO PRODUCTS: 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE AND 3M ESPE RELYX ULTIMATE CEMENT. DURING THE REPORT, THE DENTIST INDICATED THAT SOME PATIENTS HAVE EXPERIENCED SENSITIVITY WHICH ULTIMATELY RESULTED IN ROOT CANAL TREATMENT. DESPITE MULTIPLE ATTEMPTS TO OBTAIN FOLLOW-UP INFORMATION, NO ADDITIONAL INFORMATION WAS MADE AVAILABLE REGARDING EITHER THE NUMBER OF PATIENTS INVOLVED OR THE OUTCOME OF THE CASES.