OSSEOTITE® CERTAIN® INT3285Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00844868006633), received between Jun 16, 2020 and Jan 16, 2026 — classified as 14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #4 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT STARTED HAVING PAIN. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24095225 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERI-IMPLANTITIS AND THE IMPLANT WAS REMOVED. THE PROCESS WAS COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21652010 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #14 #15 #24 & #25 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. ABSCESS WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21545060 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #16 & #17 FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20052871 ↗
• InjurySep 18, 2023Adverse 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 24,25 FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. SITES PRESENTED EDEMA AND ABCESS.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 17763627 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTED THAT THE DENTAL IMPLANT LOCATED AT TOOTH #16 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED INFLAMMATION AS A SYMPTOM OF THIS EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 16885123 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS #24 & UNKNOWN FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED: EDEMA AND ABSCESS. THE DOCTOR CONFIRMS THAT THE PROCEDURE WAS COMPLETED WITH OTHER IMPLANTS AND THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH AS A RESULT OF THE EVENT.

  Patient problems: Abscess; Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 14732210 ↗
• InjuryOct 21, 2021Adverse 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.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 12671045 ↗
• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR INFORMS THAT THE PATIENT REPORTED PAIN AND THAT THE SURGICAL PROCEDURE WAS COMPLETED BY PLACING OTHER IMPLANTS. THE DOCTOR ALSO REPORTS THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 12553771 ↗
• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR INFORMS THAT THE PATIENT REPORTED PAIN AND THAT THE SURGICAL PROCEDURE WAS COMPLETED BY PLACING OTHER IMPLANTS. THE DOCTOR ALSO REPORTS THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 12553693 ↗
• InjuryMay 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829798 ↗
• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THE IMPLANT IN TOOTH LOCATION 30 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE SITE PRESENTED AN ABSCESS.

  Patient problems: Abscess; No Code Available; Unspecified Infection

  MAUDE report 10791174 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 20 WAS REMOVED BECAUSE OF PERI-IMPLANTITIS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10695979 ↗
• InjuryJun 16, 2020Adverse 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 LACK OF PRIMARY STABILITY.

  Patient problems: No Information

  MAUDE report 10159224 ↗