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Patient 1
ON (B)(6) 2012, ADDITIONAL INFORMATION WAS RECEIVED FROM THE DENTAL PROVIDER WHO DID NOT HAVE THE MEDICAL RECORD AVAILABLE AT THE TIME OF THE CALL. THIS INVOLVED A MALE IN THE (B)(6) RANGE. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT KNOWN. THE PATIENT HAD A LARGE ANTERIOR DEFECT OF TOOTH #7 REQUIRING BULK TISSUE IN THAT AREA OF PREPARATION FOR A BRIDGE. ON AN UNSPECIFIED DATE GEM 215 WAS PLACED ALONG WITH A "CT GRAFT" (CONNECTIVE TISSUE GRAFT) (MEDRA CODED OFF LABEL USE). THE PATIENT DID WELL FOR THE NEXT 5 DAYS AND THEN SWELLING DEVELOPED (AREA NOT SPECIFIED). ANTIBIOTICS WERE PRESCRIBED AND THE PATIENT WAS FOLLOWED EVERY 3 DAYS. APPROXIMATELY 10 DAYS LATER THERE WAS AN ABSCESS AND THE CT GRAFT HAD SLOUGHED. TWO WEEKS FOLLOWING THE PROCEDURE, THE DENTAL PROVIDER REQUESTED THE PATIENT HAVE A FULL RANGE OF BLOOD WORK COMPLETED. RESULTS, SHE REPORTED, WERE "BASICALLY NORMAL" WITH THE EXCEPTION OF AN ELEVATED GLUCOSE LEVEL. THE PATIENT WAS NOT KNOWN TO HAVE A HISTORY OF DIABETES AND WAS QUESTIONED BY THE DENTAL PROVIDER ABOUT THE ABNORMAL LAB VALUE. IN FOLLOW UP THE PATIENT REPORTED THAT HE HAD EATEN A DONUT PRIOR TO SUBMITTING BLOOD FOR THE LAB WORK. AS OF (B)(6) 2012, THE PATIENT WAS 4-5 WEEKS POST PROCEDURE AND REPORTEDLY HAD COMPLETELY HEALED. HOWEVER, THE DENTAL PROVIDER REPORTED, "THE VOID IS TWICE AS LARGE". THERE HAS BEEN BONE LOSS AND TISSUE LOSS. TREATMENT INFORMATION WAS NOT PROVIDED.