OSSEOTITE® FNT3210Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00844868003274), received between Nov 2, 2020 and Mar 12, 2026 — classified as 15 injuries.

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT WAS REMOVED DUE TO AN INFECTION AND BONE LOSS AT TOOTH SITE #12.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24578009 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #41 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24557969 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT PLACEMENT ON UNK DATE, PATIENT WAS UNDER REHABILITATION ON (B)(6) 2017. A PERI-IMPLANTITIS AT TOOTH SITE 42 DETECTED ON (B)(6) 2020 AND HAD A REGENERATIVE TREATMENT. NO IMPLANT WAS REMOVED. LATER ON (B)(6)2024, PERI-IMPLANTITIS RECURRENCE LED TO THE LOSS OF THE IMPLANT. THIS COMPLAINT REFERS TO THE FIRST EVENT IN 2020.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21240738 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT PLACEMENT ON UNK DATE, PATIENT WAS UNDER REHABILITATION ON (B)(6) 2017. A PERI-IMPLANTITIS AT TOOTH SITE 42 DETECTED ON (B)(6) 2020 AND HAD A REGENERATIVE TREATMENT. NO IMPLANT WAS REMOVED. LATER ON, (B)(6) 2024, PERI-IMPLANTITIS RECURRENCE LED TO THE LOSS OF THE IMPLANT. THIS COMPLAINT REFERS TO THE SECOND EVENT IN DEC ,2024.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21239739 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE IMPLANTS AT TOOTH SITES #34 & #36 WERE REMOVED DUE TO INFECTION. NO ADDITIONAL APPOINTMENT REQUIRED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20448953 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE IMPLANT AT TOOTH SITE #31 WAS REMOVED DUE TO INFECTION. ADDITIONAL APPOINTMENT REQUIRED FOR A NEW IMPLANT PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20448469 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE IMPLANT AT TOOTH SITE #34 WAS REMOVED DUE TO BONE LOSS. ADDITIONAL APPOINTMENT REQUIRED FOR A NEW IMPLANT PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: NOT INDICATED.

  Patient problems: Osteolysis

  MAUDE report 20448410 ↗
• 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: Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17006983 ↗
• InjuryMay 15, 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 12 FAILED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16928910 ↗
• InjuryFeb 13, 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: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 16361742 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 16361662 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPANTS AT TOOTH LOCATION UNK WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS REPORTED: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 13799979 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPANTS AT TOOTH LOCATION UNK WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS REPORTED: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 13799451 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPANTS AT TOOTH LOCATION UNK WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS REPORTED: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 13799380 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS PLACED AND REMOVED DURING THE SAME PROCEDURE DUE TO BONE LIMITATION. ALSO THERE WERE BONE DEHISCENCE. SITE WAS GRAFTED AFTER REMOVAL AND PATIENT WOULD CAME BACK TO DENTAL PRACTICE TO PLACE A NEW IMPLANT.

  Patient problems: No Information

  MAUDE report 10769764 ↗