Description of Event or Problem · 1
ON (B)(6) 2012, A SPONTANEOUS REPORT WAS RECEIVED BY LUITPOLD PHARMACEUTICALS, INC. VIA THE ADE LINE FROM A DENTAL PROVIDER INVOLVING GEM 215. THE DENTAL PROVIDER STATED SHE HAD AN ADVERSE SURGICAL OUTCOME WITH GEM 215. NO ADDITIONAL INFO WAS REPORTED. ON (B)(6) 2012, ADDITIONAL INFO 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) YR RANGE. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT KNOWN. THE PT HAD A LARGE ANTERIOR DEFECT OF TOOTH #7 REQUIRING BULK TISSUE IN THAT AREA IN PREPARATION FOR A BRIDGE. ON AN UNSPECIFIED DATE GEM 215 WAS PLACED ALONG WITH A "CT GRAFT" (CONNECTIVE TISSUE GRAFT) (MEDDRA CODED OFF LABEL USE). THE PT DID WELL FOR THE NEXT 5 DAYS AND THEN SWELLING DEVELOPED (AREA NOT SPECIFIED). ANTIBIOTICS WERE PRESCRIBED AND THE PT 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 PT HAVE A FULL RANGE OF BLOOD WORK COMPLETED. RESULTS, SHE REPORTED, WERE "BASICALLY NORMAL" WITH THE EXCEPTION OF AN ELEVATED GLUCOSE LEVEL. THE PT WAS NOT KNOWN TO HAVE A HISTORY OF DIABETES AND WAS QUESTIONED BY THE DENTAL PROVIDER ABOUT THE ABNORMAL LAB VALUE. IN F/U THE PT REPORTED THAT HE HAD EATEN A DONUT PRIOR TO SUBMITTING BLOOD FOR THE LAB WORK. AS OF (B)(6) 2012, THE PT WAS (B)(6) 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 INFO WAS NOT PROVIDED.