STRAUMANN EMDOGAIN

Description of Event or Problem

PT REPORTS ON (B)(6) 2013 TO STRAUMANN THAT THEY HAD A BONE GRAFT WHERE EMDOGAIN WAS USED IN (B)(6) 2013. THE PT REPORTS THAT AFTER THE PROCEDURE SHE BECAME SICK WHICH SHE THOUGHT WAS FLU. ON (B)(6) 2013, THE PT UNDERWENT AN ADD'L GRAFTING PROCEDURE WITH EMDOGAIN. AFTERWARDS, THE PT REPORTS ACHY JOINTS, ACHY MUSCLES, HEADACHES, CHILLS, SWEATS, MALAISE, EXHAUSTION, DIFFICULTY WALKING, DIFFICULTY WITH SPEAKING. PT VISITED PERIODONTIST AFTER TWO WEEKS AND HE FELT IT MAY BE RELATED TO EMDOGAIN. STRAUMANN CONTACTED THE PERIODONTIST AND REQUESTED DETAILED INFO REGARDING THIS CASE. THE PERIODONTIST REPORTED THAT THE PT UNDERWENT AN AUGMENTATION PROCEDURE ON A PERI-IMPLANT BONE DEFECT IN BONE TYPE II USING FDBA AND EMDOGAIN LOT ER887C. THE AUGMENTATION SITE WAS NOT BLEEDING AT TIME OF AUGMENTATION. PRIMARY WOULD CLOSURE WAS ACHIEVED. THE PERIODONTIST REPORTS THAT THEY DO NOT THINK THAT THE EMDOGAIN FAILED AND IT WAS NOT REMOVED. PT FELT FEVERISH AND THOUGHT THAT A REACTION TO EMDOGAIN WAS A POSSIBILITY.

Additional Manufacturer Narrative

THE CLINICIAN REPORTS THAT EMDOGAIN SYRINGE LOT NUMBER ER887C WAS USED. THE MANUFACTURE REVIEWED THE PRODUCTION RECORDS TO DETERMINE THE ARTICLE AND LOT NUMBER OF THE FINISHED GOODS BASED ON THE SYRINGE LOT NUMBER. THIS WAS THEN COMPARED TO THE SALES HISTORY FOR THIS CUSTOMER AND IT WAS DETERMINED THE ARTICLE #075.113 WITH LOT #FH765. THE COMPLAINT FILE WAS UPDATED. THE BATCH RECORD REVIEW OF EMDOGAIN SYRINGE LOT NUMBER ER887C CONFIRMED THAT THE EMDOGAIN WAS RELEASED ACCORDING TO SPECIFICATIONS. THE REVIEW OF THE COMPLAINTS DATABASE SHOWS THAT WE HAVE REC'D ONE COMPLAINT WITH LOT FH765 WHERE THE CLINICIAN REPORTS A POTENTIAL ALLERGIC REACTION (ABNORMAL SWELLING. THIS WAS REPORTED ON MDR 1222315-2013-00003. THIS CASE UNDERWENT A CLINICAL REVIEW. ACCORDING TO THIS, THE EVAL THERE IS NOTHING REPORTED THAT WOULD INDICATED THE REASON FOR THE PTS' REACTION. THE REVIEW OF THE RISK MANAGEMENT REPORT "RISK MGMT REPORT_EMDOGAIN_PREFGEL_V3" CONFIRMED THAT THE USE ON PTS SHOWING PREVIOUS SENSITIZATION TO EMDOGAIN IS ASSESSED AND REFLECTED IN THE IFU LABELING 700019 STRAUMANN EMDOGAIN (US VERSION).