RELYX ULTIMATE ADHESIVE RESIN CEMENT
Received Jan 7, 2016
Report 9611385-2016-00001 · MDR key 5351830
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
61 YR
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
SINCE THIS EVENT INVOLVED THREE MEDICAL DEVICES, THREE MANUFACTURER REPORTS ARE BEING SUBMITTED. MANUFACTURER REPORT NUMBERS 3005174370-2016-00001 AND 9611385-2016-00002 DESCRIBE THE FIRST AND THIRD DEVICE, RESPECTIVELY.
Description of Event or Problem
ON (B)(6) 2015, A DENTAL PROFESSIONAL INFORMED 3M ABOUT A PATIENT WHO REQUIRED TOOTH EXTRACTION. THIS PATIENT HAD A 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC CROWN SECURED WITH 3M ESPE RELYX ULTIMATE ADHESIVE RESIN CEMENT AND 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE. THE PATIENT, A (B)(6) YEAR OLD FEMALE PATIENT, RECEIVED THE LAVA ULTIMATE CROWN ON TOOTH #19 ON (B)(6) 2013. PATIENT WAS EXAMINED ON (B)(6) 2015, AND BITEWING X-RAYS SHOWED NO EVIDENCE OF ANY PROBLEM. PATIENT CONTACTED THE OFFICE ON (B)(6) 2015, REPORTING THAT THE AREA AROUND THE CROWN WAS PAINFUL. PATIENT CALLED AGAIN ON (B)(6) 2015, TO REPORT THAT SHE WAS IN CONSTANT PAIN AND THAT HER FACE WAS SWELLING. BITEWING AND PA X-RAYS TAKEN AT THIS TIME SHOWED EVIDENCE OF EXTREME DECAY. THE PATIENT WAS REFERRED TO A PERIODONTIST WHO PERFORMED TOOTH EXTRACTION AND BONE GRAFTING ON (B)(6) 2015. PATIENT IS REPORTED TO BE HEALING.