G-CEM AUTOMIX

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.

Description of Event or Problem

NOTIFICATION OF EVENT TO GC MADE ON 2/5/2010. DR REPORTED CEMENTING 2 CROWN (CAPS) UTILIZING G-CEM AUTOMIX. INITIAL CROWN WAS PLACED ON (B) (6) 2009. ADD'L PROCEDURE, ROOT CANAL THERAPY, WAS PRESCRIBED (9/16) FOR ONE TOOTH DUE TO SENSITIVITY THAT RESULTED FROM PULPITIS (INFLAMMATION OF THE NERVES OF THE TOOTH) AND COMPLETED ON (B) (6) 2009. SUMMARY: SENSITIVITY FROM CROWN CEMENT LEADING TO PULPITIS TWO PORCELAIN FUSED TO METAL CROWNS (TOOTH# 15 AND #19) SEATED ON (B) (6) 2009. DENTIST REPORTED THAT ENDODONTIC THERAPY WAS NEED ON TOOTH #19, ENDODONTIC THERAPY STARTED ON (B) (6) 2009 AND COMPLETED FOR PT ON (B) (6) 2009.