RELYX ULTIMATE ADHESIVE RESIN CEMENT
Received Nov 5, 2015 · Event occurred Mar 9, 2015
Report 9611385-2015-00079 · MDR key 5206299
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
55 YR
- No Code Available
Narrative
Additional Manufacturer Narrative
THE OTHER 13 PATIENT-SPECIFIC EVENTS PROVIDED BY THIS OFFICE ARE BEING REPORTED SEPARATELY. SINCE THIS EVENT INVOLVED THREE MEDICAL DEVICES, THREE MANUFACTURER REPORTS ARE BEING SUBMITTED. SECTION OF THIS REPORT DESCRIBES THE SECOND DEVICE. SECTION OF MANUFACTURER REPORT NUMBERS 3005174370-2015-00105 AND 9611385-2015-00080, DESCRIBE THE FIRST AND THIRD DEVICE, RESPECTIVELY.
Description of Event or Problem
ON (B)(6) 2015, A REPRESENTATIVE FROM THE DENTAL OFFICE PROVIDED PATIENT-SPECIFIC INFORMATION; INITIALLY, THIS OFFICE INDICATED "A COUPLE" OF PATIENTS REQUIRED ROOT CANAL TREATMENT. IN TOTAL, THE OFFICE HAS NOW PROVIDED INFORMATION ON 15 ROOT CANALS INVOLVING 14 PATIENTS. THIS REPORT DETAILS A (B)(6) FEMALE PATIENT WHO RECEIVED A CROWN MADE FROM 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC ON TOOTH #4 ON (B)(6) 2014. THIS CROWN WAS SECURED WITH 3M ESPE RELYX ULTIMATE ADHESIVE RESIN CEMENT AND 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE. ON (B)(6) 2015, THE CROWN DEBONDED AND WAS RECEMENTED. AT THE SAME TIME, THE PATIENT REPORTED BITING SENSITIVITY AND PAIN AND SHE WAS REFERRED FOR ENDODONTIC TREATMENT, WHICH WAS PERFORMED ON (B)(6) 2015. THE PATIENT'S CURRENT STATUS IS REPORTED AS FINE.