OSSEOTITE® CERTAIN® IFNT685Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00844868005148), received between Dec 8, 2020 and May 26, 2026 — classified as 9 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS CRESTAL BONE LOSS WITHIN THE PAST THREE (3) MONTHS WITH GRANULATION TISSUE AROUND THE TOP THREADS OF THE IMPLANT AT TOOTH SITE #31. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25284860 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO MINOR MOBILITY AND PAIN ASSOCIATED WITH PERI-IMPLANTITIS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24378327 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN AND SWELLING.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23650151 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22929932 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 22331512 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INFLAMMATION AROUND THE IMPLANT AT TOOTH LOCATION #3, 1.5+ YEARS POST IMPLANT PLACEMENT. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19352798 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIGNIFICANT PAIN DURING TORQUE OF THE IMPLANT ON TOOTH #3. THE DENTIST SUSPECTED PERI-IMPLANTITIS AND LOSS OF INTEGRATION AND REMOVED THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 14845593 ↗
• InjuryDec 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Edema; Inflammation; No Code Available

  MAUDE report 11005502 ↗
• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE IFNT685 IMPLANT HAD TO BE REMOVED DUE TO PERI-IMPLANTITIS. REPORTED SYMPTOMS ARE LOSS OF INTEGRATION, EDEMA AND INFLAMMATION. TOOTH LOCATION IS # 30.

  Patient problems: Edema; Inflammation; No Code Available; Unspecified Infection

  MAUDE report 10971926 ↗