RELYX LUTING LUTING CEMENT
Received Mar 14, 2017 · Event occurred Sep 12, 2011
Report 3005174370-2017-00026 · MDR key 6404691
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
IT IS NOT KNOWN WHAT ROLE, IF ANY, THE 3M CEMENT MAY HAVE PLAYED IN THIS REPORTED OUTCOME. OTHER FACTORS, SUCH AS PRIOR TOOTH HISTORY, PATIENT FACTORS OR DENTAL TREATMENT, MAY HAVE PLAYED A ROLE IN THE NEED FOR ROOT CANAL THERAPY. RELYX LUTING CEMENT HAS A HIGHLY FAVORABLE CLINICAL USAGE HISTORY AND HAS BEEN SHOWN TO BE SAFE FOR ITS INTENDED USE.
Description of Event or Problem
ON (B)(6) 2017, A DENTIST REPORTED THAT A MALE PATIENT REQUIRED A ROOT CANAL (AFFECTED TOOTH NUMBER NOT PROVIDED). ON (B)(6) 2010, 3M ESPE RELYX LUTING LUTING CEMENT WAS USED TO PLACE A CROWN . APPROXIMATELY ONE YEAR LATER, THE PATIENT SAW AN ENDODONTIST WHO SUGGESTED THAT THE PATIENT HAD PULPITIS THAT WAS LIKELY DUE TO A POTENTIAL ALLERGY TO THE CEMENT. THE ROOT CANAL WAS PERFORMED ON (B)(6) 2011.