RELYX ULTIMATE ADHESIVE RESIN CEMENT
Received Nov 6, 2015 · Event occurred Sep 24, 2014
Report 9611385-2015-00077 · MDR key 5206848
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
66 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. THIS REPORT DESCRIBES THE SECOND DEVICE. MANUFACTURER REPORT NUMBERS 3005174370-2015-00104 AND 9611385-2015-00078, 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) MALE PATIENT WHO RECEIVED A CROWN MADE FROM 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC ON TOOTH #18 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) 2014, THE PATIENT REPORTED THAT HE WAS IN PAIN AND ENDODONTIC TREATMENT WAS PERFORMED THE SAME DAY.