RELYX ULTIMATE ADHESIVE RESIN CEMENT
Received Oct 16, 2015
Report 9611385-2015-00045 · MDR key 5157612
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- No Code Available
Narrative
Additional Manufacturer Narrative
THIS REPORT IS BEING MADE TO COVER ALL FOUR POTENTIAL CASES, SINCE THE DENTAL PROFESSIONAL WAS UNWILLING TO PROVIDE ANY ADDITIONAL DETAIL. SINCE THIS EVENT INVOLVED THREE MEDICAL DEVICES, THREE MANUFACTURER REPORTS ARE BEING SUBMITTED. THIS REPORT DESCRIBES THE SECOND DEVICE. MANUFACTURER REPORT NUMBERS 3005174370-2015-00088 AND 9611385-2015-00046, DESCRIBE THE FIRST AND THIRD DEVICE, RESPECTIVELY.
Description of Event or Problem
ON (B)(6) 2015, A DENTIST INDICATED THAT UP TO FOUR OF HIS PATIENTS WITH 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC CROWNS REQUIRED ROOT CANAL TREATMENT. DETAILS REGARDING THE CROWN PLACEMENT DATES AND PATIENT INFORMATION WERE UNAVAILABLE TO 3M ESPE BECAUSE THE DENTIST REFUSED TO PROVIDE ANY FURTHER INFORMATION.