OSSEOTITE® CERTAIN® INT585Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00844868006732), received between Jun 19, 2020 and May 13, 2026 — classified as 17 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

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

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN AN UNKNOWN BUCO-DENTAL POSITION FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25159552 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT WAS REMOVED FROM TOOTH SITE #36 DUE TO AN INFECTION. ANTIBIOTIC TREATMENT WAS PRESCRIBED ON (B)(6) 2025, IMPLANT WAS REMOVED 2 MONTHS LATER. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24726895 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #27 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24326021 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE (27) WAS REMOVED DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23701892 ↗
• InjuryMay 1, 2025Adverse 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; Pain; Unspecified Infection

  MAUDE report 21945696 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BONE LOSS AROUND IMPLANTS #16/17 AND WERE REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION AND ABSCESS WERE REPORTED AS A RESULT OF THE EVENT. A BONE GRAFT HAS BEEN PERFORMED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20395066 ↗
• InjuryJun 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: Pain

  MAUDE report 19524885 ↗
• InjuryJun 7, 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 UNKNOWN DENTAL POSITIONS FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: UNKNOWN.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19486544 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 25 AND 27 WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 18922147 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 26 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18478364 ↗
• InjuryDec 4, 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 #47 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18255342 ↗
• InjurySep 26, 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 FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. PATIENT FELT PAIN AND SITE PRESENTED INFLAMMATION AND EDEMA.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 17816530 ↗
• MalfunctionSep 19, 2023Unsealed Device Packaging; Unsealed Device Packaging

  THE DOCTOR REPORTS THAT THE PACKAGING OF THE BOX WAS NOT SEALED ON THE INSIDE. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT'S HEALTH AND THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT FROM THE DOCTOR'S STOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17771991 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION 47 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 16774725 ↗
• InjuryFeb 6, 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 THE 25TH ORAL POSITION FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED "EDEMA".

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 16303139 ↗
• InjuryFeb 3, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16293740 ↗
• InjuryJan 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #3 WAS REMOVED DUE TO PERI- IMPLANTITIS.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 13193173 ↗
• InjuryJul 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Implant Pain

  MAUDE report 12245127 ↗
• MalfunctionJun 19, 2020Mechanical Problem; Mechanical Problem

  DOCTOR REPORTED MALFUNCTION. ANOTHER IMPLANT WAS PLACED ON THE SAME SURGERY THE SAME DAY.

  Patient problems: No Information

  MAUDE report 10173383 ↗