RELYX ULTIMATE ADHESIVE RESIN CEMENT
Received Nov 5, 2015 · Event occurred Feb 10, 2015
Report 9611385-2015-00071 · MDR key 5206249
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
44 YR
- No Code Available
Narrative
Additional Manufacturer Narrative
SINCE THIS EVENT INVOLVED THREE MEDICAL DEVICES, THREE MANUFACTURER REPORTS ARE BEING SUBMITTED. MANUFACTURER REPORT NUMBERS 3005174370-2015-00101 AND 9611385-2015-00072, 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 #31 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 PATIENT REPORTED SENSITIVITY TO PRESSURE AND COLD TEMPERATURES; SHE WAS REFERRED FOR ENDODONTIC TREATMENT, WHICH WAS PERFORMED ON (B)(6) 2015. THE PATIENT'S STATUS IS REPORTED AS FINE.