Description of Event or Problem · 1
DENTAL IMPLANT FAILURE. ON (B)(6) 2018 I HAD SEVEN MEGAGEN ANYONE DENTAL IMPLANTS PLACED AND ON (B)(6) 2020 WAS INFORMED BY DR. (B)(6) THAT THE POSSIBILITY OF FAILURE OF THESE IMPLANTS EXISTED. ON (B)(6) 2020 PROOF OF SUCH FAILURE WAS DETERMINED. THIS PROCEDURE ENTAILS EXTENSIVE DENTAL WORK AND PROSTHODONTIC TREATMENT REQUIRING GENERAL ANESTHESIA. BECAUSE OF THIS PRODUCT FAILURE, THE RESOLUTION WILL BE A LENGTHY ONGOING AND TRAUMATIC EXPERIENCE. OF THE SEVEN IMPLANTS, FIVE ARE 3.5 MM AND TWO ARE 4.0 MM. THERE IS PROOF THAT TO DATE THREE OF THE 3.5 MM IMPLANTS HAVE FAILED AND ARE BEING REPLACED. TWO OF THE 3.5 MM IMPLANTS HAVE THE POSSIBILITY OF FUTURE FAILURE. THIS REPORT IS SUBMITTED FOR THE DENTAL IMPLANT IN TOOTH NUMBER 3, SUCCESSIVE REPORTS ARE BEING SUBMITTED FOR DENTAL IMPLANT FAILURES IN TEETH NUMBERS 19 AND 20 ALSO. BASED ON MY INQUIRIES IT APPEARS THAT THE FDA HAS BEEN INFORMED OF THIS PRODUCT FAILURE BY DR. (B)(6) AND POSSIBLY OTHERS. AS OTHER PATIENTS HAVE EXPERIENCED THIS SAME PRODUCT FAILURE, IT APPEARS THAT THIS IS AND WILL CONTINUE TO BE AN INDUSTRY WIDE ISSUE UNLESS REMOVED FROM MARKET. THIS IS AN OBVIOUS PRODUCT FAILURE THAT NEEDS TO BE INVESTIGATED BY THE FDA IMMEDIATELY. SEE PROOF OF PRODUCT FAILURE FROM (B)(6) 2020 X-RAYS. THIS IS REPORT IS SUBMITTED FOR THE DENTAL IMPLANT FOR TOOTH NUMBER 20. SUCCESSIVE REPORTS ARE BEING SUBMITTED FOR DENTAL IMPLANT FAILURES IN TEETH NUMBERS 19. THIS REPORT IS SUBMITTED FOR THE DENTAL IMPLANT FOR TOOTH NUMBER 19. FDA SAFETY REPORT IDS# (B)(4).