OSSEOTITE® CERTAIN® INT610Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00844868006749), received between Nov 19, 2020 and Apr 13, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 27 WAS REMOVED DUE TO BONE LOSS AND INFECTION. PATIENT REFERRED PAIN. CROWN LOOSENING WAS ALSO REPORTED. THIS COMPLAINT REFERS TO THE IMPLANT REMOVAL DUE TO INFECTION AND BONE LOSS.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24857862 ↗
• InjuryDec 16, 2025Adverse 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

  MAUDE report 23821454 ↗
• InjuryOct 24, 2024Mechanical Problem; Mechanical Problem

  THE DOCTOR REPORTS THAT THE IMPLANT HAD A DEFECT AS THE HEXAGON WAS DAMAGED. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED. THE AFFECTED DENTAL POSITION IS UNKNOWN. THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON THEIR HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520643 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 20305039 ↗
• InjuryMar 23, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ALLERGIC REACTION AND PERI-IMPLANTITIS AT IMPLANT TOOTH SITE #14, WITH ASSOCIATED PAIN. THE METAL ALLERGY LET TO INFLAMMATION AND CRESTAL BONE LOSS. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Hypersensitivity/Allergic reaction; Osteolysis; Unspecified Infection

  MAUDE report 18966232 ↗
• InjurySep 16, 2022Adverse 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. SYMPTOMS CAUSED BY THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 15436393 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #44 WAS REMOVED DUE TO MEDICAL BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 14516962 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE #13 PRESENTED WITH SEVERE BONE LOSS FROM DISTAL ASPECT. LOST INTEGRATION AND WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT RETURNING 4 MONTHS FOR IMPLANT REPLACEMENT. AS A RESULT OF THIS EVENT, NO INJURY TO THE PATIENT REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 12158481 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT HAD LACK OF PRIMARY STABILITY AND WAS REMOVED. DOCTOR DID NOT PLACE OTHER IMPLANT IN THE SAME SURGERY, BONE REGENERATION HAS BEEN PERFORMED AND WAIT FOR HEALING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063226 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS UNABLE TO BE PLACED DUE TO LACK OF PRIMARY STABILITY AND SOFT TYPE III BONE AT TOOTH LOCATION # 3. IMPLANT AT TOOTH LOCATION # 3 REMOVED, AREA GRAFTED. PATIENT RETURNING IN 4 MONTHS FOR FUTURE ATTEMPT TO PLACE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11517633 ↗
• InjuryNov 19, 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 PERI-IMPLANTITIS AT TOOTH LOCATION 14.

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 10869350 ↗