OSSEOTITE® CERTAIN® IFNT610Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00844868005100), received between Jun 8, 2022 and Feb 9, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS SUBGINGIVAL CARIES AND BONE LOSS AROUND THE IMPLANT AT TOOTH SITE #2. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis

  MAUDE report 24297499 ↗
• InjuryOct 1, 2024Adverse 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; Unspecified Infection

  MAUDE report 20343699 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Osteolysis; Pain

  MAUDE report 19964302 ↗
• InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD COMPLAINTS OF TENDERNESS AT THE IMPLANT SITE AT TOOTH LOCATION #30. UPON EXAM, IT WAS ALSO NOTED THAT THE PATIENT HAD DEEP PROBING DEPTHS. THE IMPLANT WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Discomfort; Osteolysis

  MAUDE report 16312203 ↗
• InjuryJun 8, 2022Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED PERI-IMPLANTITIS ON THE IMPLANT AT TOOTH LOCATION #19. THE AREA WAS DEBRIDED AND THE IMPLANT SUBSEQUENTLY REMOVED WHEN DISCOVERED IT WAS MOBILE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 14631254 ↗