G-CEM AUTOMIX

Description of Event or Problem

NOTIFICATION OF EVENT TO GC MADE ON 2/5/2010. DR REPORTED CEMENTED CROWN (CAP) UTILIZING G-CEM AUTOMIX. INITIAL CROWN WAS PLACED ON (B) (6). ADD'L PROCEDURE, ROOT CANAL THERAPY, WAS PRESCRIBED DUE TO SENSITIVITY THAT RESULTED FROM PULPITIS (INFLAMMATION OF THE NERVES OF THE TOOTH). SUMMARY OF DENTAL PROCEDURE: SENSITIVITY FROM CROWN CEMENT LEADING TO PULPITIS PORCELAIN FUSED TO METAL THREE UNIT BRIDGE #18-20 SEATED ON (B) (6) 2008. DENTIST REPORTED THAT ENDODONTIC THERAPY WAS NEED ON TOOTH #20, ENDODONTIC THERAPY STARTED ON (B) (6) 2009 AND COMPLETED FOR PT ON (B) (6) 2009.

Additional Manufacturer Narrative

ONLY THIS DENTIST OFFICE WHICH REPORTED THIS TYPE OF EVENT. IN THE PROCESS OF REVIEWING ALL POSSIBLE G-CEM LOT DATA. WILL FILE FOLLOW-UP REPORT. PT SUMMARY CHART PROVIDED BY DR ON 3/4/2010 REVIEWED AND ON FILE.