CALIBRA CERAM
Received Jun 1, 2019
Report 2515379-2019-00012 · MDR key 8661210
Device
Generic name
Cement, Dental
Manufacturer
Dentsply CaulkModel number
NACatalog number
607194K
Lot number
180620
Product problems
- Increased Sensitivity
- Increased Sensitivity
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pain
- Sensitivity of Teeth
- Pain
- Sensitivity of Teeth
Narrative
Additional Manufacturer Narrative
THEREFORE, BECAUSE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803. THIS REPORT IS FOR THE FOURTH PATIENT. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT SEVERAL PATIENTS EXPERIENCED POST OPERATIVE PAIN AND SENSITIVITY AFTER CEMENTATION WITH PRIME & BOND ACTIVE AND CALIBRA CERAM CEMENT. THE DENTIST CLAIMS THAT ENDODONTIC THERAPY HAD TO BE PERFORMED ON SEVERAL TEETH. THE CROWNS WERE RECEMENTED WITH ANOTHER CEMENT AND BONDING AGENT.
Additional Manufacturer Narrative
EVALUATION OF RETAINED PRODUCT FAILED ON THE LOW END OF THE SPEC, MEANING THE PRODUCT WAS TOO TRANSLUCENT AND PRESENTS NO HEALTH HAZARD.