OSSEOTITE® FNT510Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00844868003373), received between Dec 4, 2019 and Apr 23, 2026 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS AT TOOTH SITE # 46 AND 27 WERE REMOVED DUE TO A PERI-IMPLANTITIS. NO IMPACT ON THE PATIENT WAS REPORTED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24965251 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN AT IMPLANT SITE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & INFLAMMATION

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24308185 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERI-IMPLANTITIS AT TOOTH SITES 45/46 OBSERVED DURING THE CLINICAL PROCEDURE. IMPLANT MOBILITY WAS ALSO REPORTED AND IMPLANTS WERE REMOVED. THE PROCESS WAS COMPLETED WITH OTHER IMPLANTS. ADDITIONAL APPOINTMENT WAS REQUIRED: RE-TREATMENT. SYMPTOMS REPORTED ON THE PATIENT: PAIN, INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21907960 ↗
• InjuryFeb 28, 2025Fracture; Fracture

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

  Patient problems: Inflammation

  MAUDE report 21489470 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #26. IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20794491 ↗
• MalfunctionOct 3, 2024Separation 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 20357740 ↗
• InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 36, 37, 46 WERE REMOVED DUE TO PERI-IMPLANTITIS. ABSCESS WAS REPORTED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19284922 ↗
• InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 36, 37, 46 WERE REMOVED DUE TO PERI-IMPLANTITIS. ABSCESS WAS REPORTED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19284868 ↗
• InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 36, 37, 46 WERE REMOVED DUE TO PERI-IMPLANTITIS. ABSCESS WAS REPORTED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19284810 ↗
• InjuryApr 15, 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 26 & 27 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.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19106550 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITES #44-46. IMPLANTS WERE REMOVED. THERE WAS NO IMPACT TO THE PATIENT ACCORDING TO PER.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18921364 ↗
• InjuryAug 18, 2021Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335399 ↗
• 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 11076986 ↗
• InjuryDec 22, 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 11054442 ↗
• InjuryJul 7, 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 LACK OF PRIMARY STABILITY. PATIENT WILL RETURN TO PLACE ANOTHER IMPLANT.

  Patient problems: No Information

  MAUDE report 10238913 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT FNT510 PLACED IN DENTAL SITE 15 HAD NO PRIMARY STABILITY AND WAS REMOVED. NO OTHER IMPLANT WAS PLACED IN THE SAME SURGERY.

  Patient problems: No Information

  MAUDE report 9574105 ↗
• 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; Unspecified Infection

  MAUDE report 9411521 ↗