RELYX ULTIMATE ADHESIVE RESIN CEMENT
Received Dec 3, 2015
Report 9611385-2015-00097 · MDR key 5265663
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Code Available
Narrative
Additional Manufacturer Narrative
3M ESPE RECEIVED THIS REPORT ON (B)(6) 2015 AND HAS ATTEMPTED TO OBTAIN PATIENT-SPECIFIC INFORMATION. SINCE THE DENTIST HAS NOT PROVIDED THE ADDITIONAL INFORMATION, PATIENT-SPECIFIC REPORTING IS NOT POSSIBLE, AND THIS REPORT IS BEING MADE TO COVER THE MULTIPLE PATIENTS IMPACTED. SINCE THIS EVENT INVOLVED THREE MEDICAL DEVICES, THREE MANUFACTURER REPORTS ARE BEING SUBMITTED. THIS REPORT DESCRIBES THE SECOND DEVICE. MANUFACTURER REPORT NUMBERS 3005174370-2015-00113 AND 9611385-2015-00098, DESCRIBE THE FIRST AND THIRD DEVICE, RESPECTIVELY.
Description of Event or Problem
ON (B)(6) 2015, A DENTIST REPORTED THAT HE HAS HAD MULTIPLE CASES OF SENSITIVITY LEADING TO ENDODONTIC TREATMENT. THE PATIENTS HAD RESTORATIONS MADE FROM 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC, WHICH WERE SECURED WITH 3M ESPE RELYX ULTIMATE ADHESIVE RESIN CEMENT AND 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE.