OSSEOTITE® FNT3211Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00844868003281), received between Mar 16, 2020 and Feb 6, 2025 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 43 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 21322942 ↗
• 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 12 AND THE IMPLANT WAS REMOVED. AFTER IMPLANTATION, REHABILITATION WAS OK ON (B)(6) 2024, BUT LATER ON (B)(6) 2025, PERI-IMPLANTITIS WAS DETECTED. SYMPTOMS REPORTED ON THE PATIENT: INFLAMMATION, ABSCESS, PAIN, EDEMA. THE PROCESS WAS NOT COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 21240149 ↗
• 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 32 AND IMPLANT WAS REMOVED. EVENT BASED ON 2023-2025; IMPLANT WAS PLACED IN 2023 AND PERI-IMPLANTITIS WAS DETECTED IN THE LAST FEW MONTHS. SYMPTOMS REPORTED ON THE PATIENT: ABSCESS, EDEMA, INFLAMMATION. THE PROCESS WAS NOT COMPLETED WITH ANOTHER IMPLANT. THE PATIENT IS CURRENTLY RECEIVING DAILY HYGIENE ASSISTANCE.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 21240087 ↗
• 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 19287804 ↗
• InjuryApr 16, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19114655 ↗
• InjuryNov 10, 2022Fracture; Fracture

  DOCTOR REPORTED THAT IMPLANT FRACTURED AT THE BODY OF THE IMPLANT AND HAD TO BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15776124 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANTS AT TOOTH SITES # 9, 11 LACKED PRIMARY STABILITY, AND WERE REMOVED. CUSTOMER REPORTED SOFT BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12798811 ↗
• 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 # 24, 22 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 12442367 ↗
• MalfunctionAug 26, 2021Fracture; Fracture

  THE DOCTOR REPORTS THAT THE COVER SCREW FRACTURED INSIDE THE IMPLANT AND THEREFORE THE DOCTOR HAD TO REMOVE THE IMPLANT. THE AFFECTED DENTAL POSITION IS 31. THE PATIENT DID NOT SUFFER ANY IMPACT ON HIS HEALTH AND THAT THE PROCEDURE WAS CONCLUDED WITH ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12369409 ↗
• MalfunctionApr 2, 2021Separation Failure; Separation Failure

  THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11608479 ↗
• InjuryDec 14, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE IMPLANTS IN TOOTH LOCATION # 10, 12 AND 14 WERE REMOVED DUE TO ALLERGIC REACTION. PATIENT CAME TO THE CLINIC WITH PAIN, AN ABSCESS AND THE SITE HAD INFLAMMATION.

  Patient problems: Abscess; Hypersensitivity/Allergic reaction; Inflammation; Pain

  MAUDE report 11002568 ↗
• InjuryMar 16, 2020Adverse 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: No Code Available; Unspecified Infection

  MAUDE report 9835282 ↗
• InjuryMar 16, 2020Adverse 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: No Code Available; Unspecified Infection

  MAUDE report 9835247 ↗