WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'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 IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.
D
Patient 1
A DENTAL LAB REPORTED A POSSIBLE ALLERGIC REACTION A PATIENT WAS EXPERIENCING FROM A (B)(6) UNIT BRIDGE FASHIONED WITH CERCON BASE. THE PATIENT REPORTED EXPERIENCING A BURNING SENSATION ON THE TISSUE IN THE AREA OF THE BRIDGE. REMOVAL OF THE DEVICE ALLEVIATES THE PATIENT'S SYMPTOMS.
N
Patient 1
THE RETURNED BRIDGE WAS IN THE MOUTH FOR OVER 9 MONTHS AND DID NOT HAVE A LOT NUMBER ASSOCIATED TO INVESTIGATE FURTHER. ZIRCONIA IS NOT LIKELY TO CAUSE AN ALLERGIC REACTION, THE CUSTOMER WILL ALSO BE INFORMED TO RELAY TO THE CLINICIAN THAT THE PATIENT SHOULD UNDERGO ALLERGY TESTING AND ALSO LOOK TO POSSIBLE CAUSES RELATING TO CEMENT USED AS WELL AS STAIN AND GLAZE APPLIED TO THE BRIDGE BY THE DENTAL LAB.