OSSEOTITE® FNT413Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00844868003342), received between Nov 8, 2019 and Apr 13, 2026 — classified as 19 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THE IMPLANTS AT TOOTH SITE 32, 34, 42,44 LOST INTEGRATION DUE TO PERI-IMPLANTITIS. IMPLANTS WERE REMOVED. PATIENT REFERRED PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24853659 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANTS AT TOOTH SITE 32, 34, 42, 44 LOST INTEGRATION DUE TO PERI-IMPLANTITIS. IMPLANTS WERE REMOVED. PATIENT REFERRED PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24853657 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANTS AT TOOTH SITE 32, 34, 42, 44 LOST INTEGRATION DUE TO PERI-IMPLANTITIS. IMPLANTS WERE REMOVED. PATIENT REFERRED PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24853655 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANTS AT TOOTH SITE 32, 34, 42, 44 LOST INTEGRATION DUE TO PERI-IMPLANTITIS. IMPLANTS WERE REMOVED. PATIENT REFERRED PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24853619 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WITH IMMEDIATE PROVISIONAL PROSTHESIS AT TOOTH SITE 23 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24404907 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITE #26. IMPLANT WAS REMOVED AND PROCEDURE WILL BE COMPLETED WITH ANOTHER IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 18229650 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INFECTION WITH INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 16144662 ↗
• InjuryMay 9, 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 22 WAS REMOVED DUE TO INFECTION AFTER IT WAS OSTEOINTEGRATED. PATIENT FELT PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 14343114 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT AT TOOTH SITE # 12 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT GOT AN INFECTION CAUSING A CYST.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 12810671 ↗
• 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 12799132 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED PERI-IMPLANTITIS WITH ABSCESS. DOCTOR PERFORMED SINUS LIFT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 11086551 ↗
• InjuryDec 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED PERI-IMPLANTITIS WITH ABSCESS, INFECTION AND BONE LOSS AT TOOTH SITES 15, 12, 22, 25.

  Patient problems: Abscess; No Code Available; Unspecified Infection

  MAUDE report 11077146 ↗
• 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. DOCTOR PRESCRIBED ANTIBIOTICS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 11077058 ↗
• 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 9835437 ↗
• InjuryMar 5, 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 INFECTION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 9792202 ↗
• InjuryDec 4, 2019Adverse 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 9411514 ↗
• InjuryDec 4, 2019Adverse 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; No Code Available

  MAUDE report 9411476 ↗
• InjuryDec 3, 2019Adverse 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 9400072 ↗
• InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. AS A RESULT, THE IMPLANT WAS REMOVED FROM TOOTH SITE 2. THE PATIENT ALSO HAD PAIN AND INFLAMMATION AS A CONSEQUENCE.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 9298001 ↗