OSSEOTITE® CERTAIN® IOSS410Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00844868007081), received between Nov 27, 2019 and Mar 31, 2026 — classified as 12 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #29 WAS REMOVED DUE TO EARLY CRESTAL BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 24746661 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. TOOTH SITE #13.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22553239 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #24 FAILED DUE TO AN INFECTION. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 21545336 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS INFECTION AT IMPLANT SITE # 4. IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: NONE INDICATED.

  Patient problems: Unspecified Infection

  MAUDE report 13938290 ↗
• InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED IMPLANT TOOTH #26 WAS UNABLE TO PLACE DUE TO A LACK OF PRIMARY STABILITY AND WAS REMOVED. NO OTHER IMPLANT HAS BEEN PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12786228 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT DID NOT ACHIEVE PRIMARY STABILITY DURING IMPLANT PLACEMENT. DOCTOR DID NOT COMPLETE THE PROCEDURE PLACING OTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12209617 ↗
• InjuryJun 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT AT TOOTH #29 WAS UNABLE TO PLACE DUE TO LACK OF PRIMARY STABILITY, AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11988647 ↗
• InjuryMay 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT AT TOOTH LOCATION UNKNOWN WAS REMOVED DUE TO LACK OF PRIMARY STABILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905542 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO A PERI-IMPLANTITIS. BONE LOSS ALSO REPORTED. ADDITIONAL APPOINTMENT REQUIRED: YES, TO PLACE A NEW IMPLANT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection

  MAUDE report 11326734 ↗
• 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 LOSS OF INTEGRATION WITH PERI-IMPLANTITIS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10498678 ↗
• InjuryJan 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR WAS UNABLE TO PLACE THE IMPLANT INTO THE PATIENT'S OSTEOTOMY DUE TO A LACK OF PRIMARY STABILITY.

  Patient problems: No Information

  MAUDE report 9597133 ↗
• InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT PRIMARY STABILITY WAS NOT ACHIEVED FOR IMPLANT IOSS410. TOOTH SITE #20.

  Patient problems: No Information

  MAUDE report 9384705 ↗