OSSEOTITE® FNT485Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00844868003366), received between Feb 18, 2020 and Dec 3, 2025 — classified as 24 injuries, 1 malfunction.

The most frequently reported specific device problem is “Separation Failure” (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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #27 WAS REMOVED DUE TO AN INFECTION. PATIENT ALSO EXPERIENCED PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23702361 ↗
• MalfunctionNov 14, 2025Separation Failure; Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554330 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITES 45/46/47/44 OBSERVED DURING THE CLINICAL PROCEDURE AND 5 IMPLANTS WERE REMOVED. EXTERNAL PATIENT WENT TO THE CLINIC WITH PERI-IMPLANTITIS AND BONE LOSS AROUND THE IMPLANT. THE PROCESS WAS NOT COMPLETED WITH ANOTHER IMPLANTS AND ADDITIONAL APPOINTMENT WILL BE REQUIRED. ABSCESS, INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21591740 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITE 27 ALONG WITH IMPLANT LOOSENING. PERI-IMPLANTITIS WAS DETECTED TWO YEARS AFTER THE IMPLANTATION DATE. SYMPTOMS REPORTED ON THE PATIENT: INFLAMMATION. THE PROCESS WAS NOT COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21239190 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH #11 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT WOULD HAVE TO RETURN TO PLACE A NEW IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20011124 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 34, 36, 37, 45, 46, 47 WERE REMOVED DUE TO PERI-IMPLANTITIS WITH ABSCESS. PATIENT REFERRED PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19296530 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 34, 36, 37, 45, 46, 47 WERE REMOVED DUE TO PERI-IMPLANTITIS WITH ABSCESS. PATIENT REFERRED PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19296495 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 34, 36, 37, 45, 46, 47 WERE REMOVED DUE TO PERI-IMPLANTITIS WITH ABSCESS. PATIENT REFERRED PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19296487 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 34, 36, 37, 45, 46, 47 WERE REMOVED DUE TO PERI-IMPLANTITIS WITH ABSCESS. PATIENT REFERRED PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19296460 ↗
• InjuryMay 10, 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 37 36 35 46 & 44 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. BONE TYPE: III. THE DOCTOR REPORTED : INFLAMMATION + SMOKER + ABSCESS + POOR ORAL HYGIENE.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19287539 ↗
• InjuryMay 10, 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 37 36 35 46 & 44 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. BONE TYPE: III. THE DOCTOR REPORTED : INFLAMMATION + SMOKER + ABSCESS + POOR ORAL HIGYENE.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19287394 ↗
• InjuryMay 10, 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 37, 36, 35, 46, AND 44 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: III. THE DOCTOR REPORTED: INFLAMMATION, SMOKER, ABSCESS AND POOR ORAL HYGIENE.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19287291 ↗
• InjuryMay 10, 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 12 22 14 & 24 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. BONE TYPE: III THE DOCTOR REPORTED : SMOKER + POOR ORAL HYGIENE + ABSCESS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19285772 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INFECTION WITH INFLAMMATION AND PAIN AT TOOTH SITE 29 DURING HEALING PHASE. DOCTOR ALSO INDICATED NECROSIS OF VESTIBULAR BONE WALL. THERE HAS BEEN A DELAY IN THE PROCEDURE DUE TO OSSIFICATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 17553649 ↗
• InjuryMay 25, 2023Adverse 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Necrosis

  MAUDE report 17006410 ↗
• InjuryApr 12, 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 INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16728383 ↗
• InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT AT TOOTH SITE # 14 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 12788004 ↗
• InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE IMPLANT LOCATED IN DENTAL POSITION NUMBER #23 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR CONFIRMS THAT THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT ON THE SAME DAY AND THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH. BONE GRAFT WAS PLACED AFTER IMPLANT REMOVAL.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 12787339 ↗
• InjurySep 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANTS AT TOOTH SITES # 29, 30 WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 12445596 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANTS AT TOOTH SITES # 21, 19 WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 12439681 ↗
• InjuryDec 29, 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. NEW IMPLANT WOULD BE PLACED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 11087519 ↗
• InjuryAug 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 problems: No Code Available; Unspecified Infection

  MAUDE report 10377700 ↗
• InjuryAug 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10367208 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT FNT485 WAS REMOVED DUE TO LACK OF PRIMARY STABILITY WHEN PLACING. ADDITIONAL APPOINTMENT REQUIRED: YES, TO PLACE A NEW IMPLANT.

  Patient problems: No Information

  MAUDE report 10249460 ↗
• InjuryFeb 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT THE FNT485 IMPLANT WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9719667 ↗