Description of Event or Problem · 1
RE: DEFECTIVE DENTAL SURGICAL IMPLANTS; MY NAME IS (B)(6). THE FOLLOWING IS REGARDING DEFECTIVE DENTAL IMPLANTS. THIS PROBLEM HAS NOT ONLY AFFECTED ME, BUT THE DENTIST AS WELL, FINANCIALLY. ADDITIONALLY, THIS HAS AFFECTED AT LEAST TEN OTHER PATIENTS OF OUR DENTIST, SO FAR. THE DENTIST IS: DOCTOR (B)(6), B.D.S., M.S., F.A.C.P. (B)(6). THE MANUFACTURER IS: MEGAGEN ANYONE HTTPS://IMEGAGEN.COM/PRODUCT/1301/ ANYONE ¿ MEGAGEN IMPLANT ANYONE FOR ANY IMPLANTOLOGIST AND ANY PATIENT. OFFERING A BETTER EXPERIENCE FOR BOTH DENTISTS AND PATIENTS. FOR DENTISTS: CONVENIENT IMPLANT PLACEMENT, STRONG INITIAL STABILITY, EXCELLENT SOFT AND HARD TISSUE RESPONSE, AND SHORTER OVERALL TREATMENT TIME. FOR PATIENTS: MINIMALLY INVASIVE SURGERY WITH LESS PAIN, SHORTER HEALING TIME, AND BETTER ESTHETIC RESULTS. IMEGAGEN.COM ADDRESS/CONTACT: ABODE 45, SECHEON-RO 7-GIL DASA-EUP (B)(6). THE FOLLOWING IS THE APPROXIMATE SEQUENCE OF WHAT OCCURRED. IN EARLY 2018 I CONTACTED DR. (B)(6) AFTER BEING REFERRED TO HIM BY OUR FAMILY DENTIST. I HAD DEVELOPED DETERIORATING TEETH. THIS RESULTED IN THE NEED TO HAVE NUMEROUS TEETH EXTRACTED AND DENTAL IMPLANTS INSTALLED TO CORRECT THIS PROBLEM. I CONTRACTED WITH DR. (B)(6) TO PERFORM THIS PROCEDURE. THE COST TO DO THIS WAS APPROXIMATELY (B)(6). THE IMPLANTS WERE DONE OVER A PERIOD OF ABOUT 11 MONTHS. THE PROCEDURE WAS, IN BRIEF, EXTRACTION OF EXISTING TEETH, BONE GRAFTS, SURGERY TO INSTALL THE TITANIUM IMPLANTS INTO THE JAW BONES, THE HEALING PROCESS TO PROVIDE ADEQUATE TIME FOR THE IMPLANTS TO ADHERE TO THE BONE, SURGICAL ACCESS TO THE IMPLANTS TO MAKE IMPRESSIONS FOR THE ARTIFICIAL TEETH TO BE MADE AND THEN AGAIN SURGICAL ACCESS TO THE IMPLANTS TO SECURE THE ARTIFICIAL TEETH. I ADHERE TO THE DOCTORS REQUEST TO HAVE MY TEETH CLEANED AT HIS OFFICE BY HIS DENTAL ASSISTANT. ON (B)(6) 2019, I WENT TO HAVE MY TEETH CLEANED AND INFORMED THEM THAT ONE TOOTH FELT LOOSE. AN EXAM AND X-RAY SHOWED THAT TWO OF THE TITANIUM IMPLANTS WERE CRACKED. THIS THEN TURNED INTO A THREE HOUR SURGERY IN WHICH THE DOCTOR HAD TO REMOVE THE TITANIUM IMPLANTS FROM THE JAW BONES. HE HAD TO THEN INSTALL NEW IMPLANTS INTO THE JAW BONE AND STITCH THE GUM TISSUE OVER THE INCISIONS AND AGAIN HAD TO WAIT FOR THE IMPLANTS TO ADHERE TO THE BONE. THIS TOOK SEVERAL MONTHS. THE PROCESS FOR THE COMPLETION OF THIS WAS THE SAME AS THE ORIGINAL STEPS. THIS WAS COMPLETED ON (B)(6) 2019. THERE IS A THIRD IMPLANT THAT MAY CRACK AND REQUIRE ADDITIONAL REPLACEMENT, IT IS BEING MONITORED BY THE DOCTOR. THE REMOVAL OF THE DEFECTIVE IMPLANTS NOT ONLY WERE PAINFUL BUT CAUSED ADDITIONAL PROBLEMS, IN THAT, I ONCE AGAIN HAD TO MONITOR WHAT I ATE DUE TO BEING UNABLE TO PROPERLY CHEW FOOD. THIS WAS VERY UPSETTING BOTH PHYSICALLY AND MENTALLY TO ME. THE TITANIUM IMPLANTS, FROM WHAT I SAW ON THE X-RAYS, CRACKED FROM THE TOP TO THE BOTTOM OF THE DEVICE. DOCTOR (B)(6) HAS ABSORBED ALL OF THE COSTS ASSOCIATED WITH THIS PROBLEM. HE IN NO WAY RESPONSIBLE FOR THE RESULTANT PROBLEM WITH THE DEFECTIVE PRODUCTS. FDA SAFETY REPORT ID# (B)(4).