Description of Event or Problem · 0
DENTAL IMPLANTS: SIN DENTAL USA. SINCE APPROXIMATELY EARLY 2025, CLINICIANS HAVE REPORTED A NUMBER OF DENTAL IMPLANT FAILURES ASSOCIATED WITH A SPECIFIC IMPLANT SYSTEM. BASED ON CONVERSATIONS WITH MULTIPLE PROVIDERS, THE ESTIMATED OCCURRENCE APPEARS HIGHER THAN TYPICAL INDUSTRY RATES. I UNDERSTAND THAT THE COMPANY HAS PROVIDED REPLACEMENT IMPLANTS TO AFFECTED PROVIDERS; HOWEVER, I AM NOT AWARE OF ADVERSE EVENT REPORTS BEING SUBMITTED TO THE FDA REGARDING THESE FAILURES. I ALSO UNDERSTAND THAT THE COMPANY REVIEWED THE ISSUE INTERNALLY AND SUGGESTED THE ROOT CAUSE MAY RELATE TO PACKAGING CONDITIONS IN CERTAIN SHIPMENTS, BUT IMPLANT FAILURES HAVE CONTINUED TO BE REPORTED BEYOND THOSE BATCHES. THIS INFORMATION IS BEING SUBMITTED BECAUSE IT MAY INDICATE A POTENTIAL REPORTING OBLIGATION UNDER FDA REGULATIONS, AND THERE IS A CONCERN THAT PATIENT SAFETY COULD BE IMPACTED. I AM REPORTING INFORMATION THAT MAY INDICATE A REGULATORY COMPLIANCE CONCERN RELATED TO MEDICAL DEVICE REPORTING REQUIREMENTS FOR DENTAL IMPLANTS.