RELYX ULTIMATE ADHESIVE RESIN CEMENT

Additional Manufacturer Narrative

THIS REPORT IS BEING MADE TO COVER ALL FIVE POTENTIAL CASES, SINCE THE DENTAL PROFESSIONAL DID NOT PROVIDE ADDITIONAL DETAIL. SINCE THIS EVENT INVOLVED TWO MEDICAL DEVICES, TWO MANUFACTURER REPORTS ARE BEING SUBMITTED. THIS REPORT DESCRIBES THE FIRST DEVICE. MANUFACTURER REPORT NUMBER 9611385-2015-00048 DESCRIBES THE SECOND DEVICE, RESPECTIVELY.

Description of Event or Problem

ON (B)(6) 2015, A REPRESENTATIVE FROM A DENTAL OFFICE CONTACTED 3M ESPE TO INQUIRE ABOUT PROPER USAGE OF TWO PRODUCTS: 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE AND 3M ESPE RELYX ULTIMATE ADHESIVE RESIN CEMENT. DURING THE REPORT, THE REPRESENTATIVE INDICATED THAT UP TO FIVE 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.

Additional Manufacturer Narrative

SINCE FOLLOW-UP INFORMATION SUGGESTED THAT RELYX UNICEM 2 CEMENT WAS USED INSTEAD RELYX ULTIMATE ADHESIVE RESIN CEMENT (AS NOTED IN REPORT OF THIS REPORT 9611385-2015-00047) AND SCOTCHBOND UNIVERSAL (AS NOTED IN REPORT OF MANUFACTURER REPORT NUMBER 9611385-2015-00048), AN ADDITIONAL REPORT IS BEING SUBMITTED FOR RELYX UNICEM 2 UNDER MANUFACTURER REPORT NUMBER 9611385-2015-00095.

Description of Event or Problem

UPDATED INFORMATION WAS RECEIVED ON (B)(6) 2015 BY THE REPORTING DENTAL OFFICE WHICH SUGGESTED THAT IT IS POSSIBLE THAT NEITHER 3M ESPE RELYX ULTIMATE CEMENT NOR 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE WERE IN USE BY THE PRACTICE WHEN THE REPORTED ROOT CANAL TREATMENTS WERE REQUIRED. INSTEAD THE OFFICE SUGGESTS THAT IT MAY HAVE BEEN 3M ESPE RELYX UNICEM 2 CEMENT THAT WAS USED, THEREFORE A NEW MEDWATCH FORM FOR THIS PRODUCT HAS BEEN PREPARED AND FILED.