OSSEOTITE® CERTAIN® IOSS485Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00844868007142), received between Aug 12, 2020 and Aug 16, 2026 — classified as 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (4 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem

  Doctor reported that implant was removed due to Peri-implantitis with complete loss of integration.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50268120 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO PERI-IMPLANTITIS WITH TOTAL LOSS OF INTEGRATION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25221614 ↗
• InjuryApr 21, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 16, 15 WERE REMOVED DUE TO PERI-IMPLANTITIS WITH TOTAL LOSS OF INTEGRATION. PATIENT HAS BEEN SCHEDULED FOR NEW IMPLANT PLACEMENT IN APROXIMATELY 3 MONTHS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24936785 ↗
• InjuryApr 21, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 16, 15 WERE REMOVED DUE TO PERI-IMPLANTITIS WITH TOTAL LOSS OF INTEGRATION. PATIENT HAS BEEN SCHEDULED FOR NEW IMPLANT PLACEMENT IN APPROXIMATELY 3 MONTHS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24936682 ↗
• InjuryApr 18, 2026Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 26 WAS REMOVED DUE TO PERI-IMPLANTITIS WITH TOTAL LOSS OF INTEGRATION. PATIENT HAS BEEN SCHEDULED FOR NEW IMPLANT PLACEMENT IN APPROXIMATELY 3 MONTHS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24919744 ↗
• InjuryApr 18, 2026Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 45 WAS REMOVED DUE TO PERI-IMPLANTITIS WITH TOTAL LOSS OF INTEGRATION. PATIENT HAS BEEN SCHEDULED FOR NEW IMPLANT PLACEMENT IN APPROXIMATELY 3 MONTHS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24919743 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED SCREW FRACTURE AT TOOTH SITE 26 AND PERI-IMPLANTITIS WITH TOTAL LOSS OF INTEGRATION. PATIENT HAS BEEN RESCHEDULED FOR NEW IMPLANT PLACEMENT IN APPROX. 3 MONTHS. THIS REPORT REFERS TO PERI-IMPLANTITIS EVENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24517496 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24500200 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 17 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21888670 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 11 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19663487 ↗
• InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 16 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19523755 ↗
• InjuryMay 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 26 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT HAS BEEN RESCHEDULED FOR BONE REGENERATION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19403990 ↗
• InjuryMar 20, 2024Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Sinus Perforation; Unspecified Infection

  MAUDE report 18942819 ↗
• MalfunctionDec 15, 2023Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18338483 ↗
• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED PERI-IMPLANTITIS AT TOOTH SITE 26. A NEW IMPLANT WILL BE PLACED IN 3 MONTHS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17910654 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERI-IMPLANTITIS. PATIENT HAS BEEN RESCHEDULED FOR NEW IMPLANT PLACEMENT IN 3 MONTHS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15536123 ↗
• InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED PERI-IMPLANTITIS AT TOOTH SITE 26. PATIENT HAS BEEN RESCHEDULED FOR NEW IMPLANT PLACEMENT IN APROX. 3 MONTHS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15463833 ↗
• InjuryAug 30, 2022Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS AT THE SITE WITH A LOSS OF INTEGRATION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15320566 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED PERI-IMPLANTITIS WITH INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 14236610 ↗
• InjuryFeb 12, 2021Fracture; Fracture

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

  Patient problems: No Information

  MAUDE report 11320834 ↗
• InjurySep 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT REMOVED DUE TO PERI-IMPLANTITIS. PATIENT ALSO HAD ABCESS.

  Patient problems: Abscess; No Code Available; Unspecified Infection

  MAUDE report 10498689 ↗
• InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10395192 ↗