OSSEOTITE® NT485Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00844868012054), received between Oct 3, 2019 and Sep 28, 2026 — classified as 24 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant was removed due to a peri-implantitis at tooth site 16.Abscess, pain and inflammation were reported as a consequence.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 50914636 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT WAS PLACED WITH SINUS LIFT AND PRIMARY STABILITY OF 40 NW. AT TOOTH SITE 26. THREE WEEKS LATER PRESENTED MOBILITY AND IMPLANT WAS REMOVED DUE TO INFECTION. NO OTHER IMPLANT WAS PLACED DURING THE SAME PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 24700207 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #45 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN AND ABSCESS.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24328142 ↗
• MalfunctionDec 11, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANT BECOMES LOOSE IN THE DELIVERY SYSTEM DUE TO DAMAGE AT THE CONNECTION POINT. THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT OF THE SAME SIZE. TOOTH SITE: 36.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776643 ↗
• InjuryNov 18, 2025Adverse 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: Osteolysis; Unspecified Infection

  MAUDE report 23585665 ↗
• InjurySep 3, 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 44 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22952072 ↗
• MalfunctionJun 13, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22200513 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED BONE LOSS AT TOOTH SITE 16. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain

  MAUDE report 21958626 ↗
• InjuryMar 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT FAILED DUE TO AN ALLERGIC REACTION. 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: Hypersensitivity/Allergic reaction; Inflammation

  MAUDE report 21534683 ↗
• InjuryDec 7, 2024Adverse 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 DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20873598 ↗
• InjuryNov 30, 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 #35 #36 & #45 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20813682 ↗
• InjurySep 25, 2024Adverse 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 THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED : INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20299907 ↗
• 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 16 AND 36 WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 18921801 ↗
• MalfunctionNov 24, 2023Separation 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 18203972 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #27 FAILED AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF EVENT: ABSCESS AND PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 17465065 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE DOCTOR THAT THE PATIENT DEVELOPED PERI-IMPLANTITIS AT IMPLANT TOOTH SITE #17. THEREFORE, THE IMPLANT WAS REMOVED DUE TO FAILURE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17321610 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITE 23 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16396267 ↗
• InjuryJan 18, 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 45 WAS REMOVED DUE TO PERI-IMPLANTITIS.SYMPTOMS CAUSED BY THE EVENT: PAIN AND ABSCESS.

  Patient problems: Abscess; Osteolysis; Pain; Unspecified Infection

  MAUDE report 16199085 ↗
• InjuryMar 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION #21 FAILED DUE TO A BONE LOSS WITHOUT ANY TYPE OF IMPACT ON THE PATIENT. THE DOCTOR CONFIRMS THAT THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT AND THE PATIENT WILL HAVE TO RETURN IN THE FUTURE. THE DOCTOR REPORTED PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 13659861 ↗
• MalfunctionNov 12, 2021Separation Failure; Separation Failure

  IT WAS REPORTED THAT ONCE THE IMPLANT IS PLACED, HE CANNOT REMOVE THE MOUNT BECAUSE IT WAS STUCK IN THE HEXAGON. THE DOCTOR CONFIRMS THAT THE DENTAL SURGICAL PROCEDURE WAS ACCOMPLISHED WITH ANOTHER IMPLANT. THE DOCTOR CONFIRMS THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12802581 ↗
• InjuryDec 28, 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.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 11076675 ↗
• InjuryNov 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THE IMPLANT IN TOOTH LOCATION 19 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: No Code Available

  MAUDE report 10917889 ↗
• InjuryAug 12, 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 ALSO HAD INFLAMMATION AND ABSCESS.

  Patient problems: Unspecified Infection

  MAUDE report 10395204 ↗
• InjuryJun 12, 2020Adverse 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. SCARCE BONE. ANOTHER IMPLANT WAS PLACED.

  Patient problems: No Code Available

  MAUDE report 10147725 ↗
• InjuryJun 12, 2020Adverse 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: Unspecified Infection

  MAUDE report 10147567 ↗