RELYX ULTIMATE ADHESIVE RESIN CEMENT
Received May 8, 2015 · Event occurred Mar 3, 2013
Report 3005174370-2015-00030 · MDR key 4761792
Device
Product problems
- Loss of or Failure to Bond
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
3M ESPE LEARNED THAT A CUSTOMER WHO HAD A FULL COVERAGE CROWN MADE FROM LAVA ULTIMATE REQUIRED ENDODONTIC TREATMENT. THE CROWN WAS PLACED ON (B)(6) 2012. ON (B)(6) 2012 THE CROWN WAS DEBONDED AND WAS RE-CEMENTED WITH 3M ESPE RELYX ULTIMATE CEMENT. THE PATIENT WAS SEEN ON (B)(6) 2013, AND AT THAT TIME, A RECOMMENDATION FOR ENDODONTIC TREATMENT WAS MADE; TREATMENT WAS EXECUTED ON (B)(6) 2013. NO FURTHER INFO IS AVAILABLE REGARDING PATIENT STATUS OR ON SPECIFIC LOTS OF PRODUCT USED.
Additional Manufacturer Narrative
THIS REPORT ARISES FROM A RECENT RETROSPECTIVE REVIEW OF RECORDS. THERE WERE TWO DEVICES INVOLVED IN THIS EVENT. THIS REPORT DESCRIBES THE SECOND DEVICE AND MFR REPORT NUMBER 3005174370-2015-00029 PROVIDES INFO ON THE FIRST DEVICE INVOLVED IN THIS EVENT.