CALIBRA ESTHERIC RESIN CEMENT
Received Oct 3, 2014
Report 2515379-2014-00064 · MDR key 4186109
Device
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Inflammation
- Reaction
Narrative
Description of Event or Problem
IN THIS EVENT IT WAS REPORTED THAT A PT EXPERIENCED GINGIVAL INFLAMMATION AFTER CEMENTATION OF SEVERAL VENEERS WITH CALIBRA CEMENT, ALONG WITH OTHER MATERIALS. SHE UNDERWENT FLAP REFLECTION AND CLEANING WITH A PERIODONTIST TO SEE THE POSSIBILITY OF THE EXCESS CEMENT. THE PT IS STILL EXPERIENCING INFLAMMATION AND IS GOING TO SEE A DOCTOR FOR ALLERGY TESTING.
Additional Manufacturer Narrative
WHILE IT IS UNK IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVAL AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.