RELYX LUTING LUTING CEMENT
Received Feb 21, 2017
Report 3005174370-2017-00007 · MDR key 6345042
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
47 YR
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, IT IS NOT KNOWN WHAT ROLE, IF ANY, THE RELYX LUTING CEMENT MAY HAVE PLAYED IN THE REPORTED OUTCOME. OTHER FACTORS, SUCH AS THE CROWN MARGIN BEING TOO CLOSE TO THE BONE LEVEL, MAY HAVE CAUSED THE PAIN EXPERIENCED BY THE PATIENT, WHICH RESULTED IN THE CROWN LENGTHENING PROCEDURE AND ROOT CANAL.
Description of Event or Problem
ON (B)(6) 2016, A DENTIST REPORTED THAT A (B)(6) FEMALE REQUIRED A ROOT CANAL PROCEDURE ON TOOTH # 29. THIS TOOTH HAD A CROWN (BRAND UNKNOWN) SEATED ON (B)(6) 2016 WITH 3M ESPE RELYX LUTING CEMENT. THE DENTIST REPORTED THAT A CROWN LENGTHENING PROCEDURE WAS ALSO PERFORMED IN ADDITION TO THE ROOT CANAL.