POLY F INTRO 70G/40ML

Additional Manufacturer Narrative

SINCE THIS EVENT RESULTED IN MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE DEFINITION OF A REPORTABLE EVENT PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT POLY F INTRO 70G/40ML THAT WAS USED IN TREATMENT, THE PATIENT PRESENTED WITH A TOOTHACHE. AFTER EXAMINATION THE PATIENT WAS FOUND TO HAVE COLD SENSITIVITY AND DIAGNOSED AN ACUTE EXACERBATION OF CHRONIC PULPITIS. ROOT CANAL TREATMENT WAS PERFORMED, FOLLOWED BY TOOTH PREPARATION FOR RESTORATION AND PLACEMENT OF A CROWN. AN INTRAORAL SCAN WAS TAKEN FOR IMPRESSION, AND THE PATIENT AWAITED CROWN DELIVERY. ON THE MORNING OF (B)(6), THE PATIENT RETURNED FOR CROWN TRY-IN. THE CROWN WAS CEMENTED USING ZINC POLYCARBOXYLATE CEMENT. THE PATIENT WAS ADVISED TO AVOID STICKY FOODS AND CHEWING HARD SUBSTANCES, AND TO RETURN FOR FOLLOW-UP IF ANY ISSUES AROSE. ON THE MORNING OF (B)(6), THE PATIENT REVISITED THE CLINIC REPORTING THAT THE CROWN HAD FELL OFF. AT THE TIME OF DISLODGEMENT, THE PATIENT BIT DOWN ONTO THE OPPOSING TOOTH; THE CROWN IMPACTED THE GINGIVA, CAUSING SIGNIFICANT PAIN, AND THE OPPOSING TOOTH WAS ALSO PAINFUL. UPON EXAMINATION, THE CLINICIAN FOUND A SMALL CHIP ON THE OPPOSING TOOTH, ALONG WITH GINGIVAL REDNESS, SWELLING, AND BLEEDING. IMMEDIATE MANAGEMENT INCLUDED DISINFECTION AND HEMOSTASIS. THE CHIPPED AREA ON THE OPPOSING TOOTH WAS ADJUSTED AND RESTORED. AFTER BLEEDING WAS CONTROLLED, PERIODONTAL GEL WAS APPLIED TO THE INFLAMED GINGIVAL AREA. THE DISLODGED CROWN WAS INSPECTED AND FOUND TO BE INTACT WITHOUT DAMAGE. THE CROWN WAS ADJUSTED AND POLISHED, THEN BOTH THE CROWN AND THE TOOTH WERE DISINFECTED BEFORE RE-CEMENTATION. THE PATIENT IS FINE NOW AFTER FOLLOW UP.