OSSEOTITE® CERTAIN® IFNT510Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00844868005056), received between Jan 30, 2020 and Sep 17, 2026 — classified as 28 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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. 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant was removed due to an infection at tooth site 19. Implant become sore to chew on and patient was having "squishy" noise.Patient suffered from pain.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50798772 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24314051 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #15 WAS REMOVED DUE TO BONE LOSS. IT WAS NOTED THAT THERE WAS INADEQUATE BONE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN AND SWELLING.

  Patient problems: Osteolysis; Pain; Swelling/ Edema

  MAUDE report 23650220 ↗
• InjuryNov 18, 2025Fracture; Fracture

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Inflammation; Pain

  MAUDE report 23586533 ↗
• InjurySep 2, 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

  MAUDE report 22946539 ↗
• InjuryMar 7, 2025Adverse 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 AND INFECTION. AT THE TIME OF UNCOVERED, GRANULATION TISSUE NOTED WITH ACUTE BONE LOSS. TOOTH # 30.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21546401 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21039750 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #12 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21035207 ↗
• InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PT HAD NO ISSUE UNTIL RECENTLY. STARTED MOVEMENT/LOOSENING OF TOOTH. THE IMPLANT WAS REMOVED DUE TO PERI IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION. TOOTH # 14 (UNIVERSAL).

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20486325 ↗
• MalfunctionOct 11, 2024Mechanical Problem; Mechanical Problem

  THIS REPORT IS BEING SUBMITTED TO RETRACT THE INITIAL REPORT, MFR REPORT NUMBER 0001038806-2024-02316 THAT WAS SUBMITTED ON OCTOBER 11, 2024 AS THIS EVENT HAD ALREADY BEEN SUBMITTED AND IS A DUPLICATE OF MFR REPORT NUMBER 0001038806-2024-02271 THAT WAS SUBMITTED ON OCTOBER 4, 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20431925 ↗
• MalfunctionOct 4, 2024Mechanical Problem; Mechanical Problem

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371463 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED PERI-IMPLANTITIS. PAIN/SWELLING OF GINGIVA, TOOTH 30 (UNIVERSAL). THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19622976 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED ONE (1) YEAR POST-OP FOR FINAL CHECK BEFORE PROCEEDING WITH THE CROWN. BONE LOSS WAS NOTED AND THE IMPLANT AT TOOTH LOCATION #14 WAS REVERSED OUT WITH 15 NCM TORQUE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 19558904 ↗
• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED THREE (3) MONTHS LATER WITH GRANULATION TISSUE AND BUCCAL FISTULA AROUND THE IMPLANT AT TOOTH LOCATION #30. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 16905327 ↗
• InjuryMar 4, 2022Adverse 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: Abscess; Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 13665921 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 12620350 ↗
• InjuryAug 26, 2021Adverse 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. AN ABSCESS WAS A REPORTED SYMPTOM. TOOTH #19.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 12375416 ↗
• InjuryJul 7, 2021Adverse 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 SIGNIFICANT BONE LOSS AND PAIN AT THE SITE. IT WAS NOT INDICATED IF THE PATIENT WOULD RETURN FOR ADDITIONAL APPOINTMENTS. TOOTH #18.

  Patient problems: Osteolysis; Pain

  MAUDE report 12129509 ↗
• InjuryMar 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE IFNT510 IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH SITE #15. ABSCESS, PAIN, EDEMA AND INFLAMMATION ARE REPORTED AS CONSEQUENCES OF THE INFECTION.

  Patient problems: Abscess; Inflammation; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 11504086 ↗
• InjuryNov 26, 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 PERI-IMPLANTITIS AT TOOTH LOCATION 2. INFLAMMATION WAS ALSO REPORTED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 10908134 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10690981 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE IFNT510 IMPLANT WAS PLACED ON (B)(6) 2018, AND THERE WERE NO ADVERSE REACTIONS AFTER PLACEMENT. ONE YEAR LATER, THE PATIENT REPORTED IMPLANT LOOSENESS AND PERI-IMPLANTITIS WAS FOUND THROUGH EXAMINATION, SO THE IMPLANT WAS REMOVED. BONE RESORPTION. TOOTH LOCATION #2.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10638344 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # LR5 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. PER INDICATED: THE IMPLANT WAS PLACED ON (B)(6) 2017, AND THERE WERE NO ADVERSE REACTIONS AFTER PLACEMENT. TWO YEARS LATER, THE PATIENT REPORTED DISCOMFORT AND INFECTION WAS FOUND THROUGH EXAMINATION, SO THE IMPLANT WAS REMOVED. ADDITIONAL APPOINTMENT REQUIRED: NONE REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA.

  Patient problems: Edema; No Code Available; Unspecified Infection

  MAUDE report 10619249 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 7 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. PER INDICATED: THE IMPLANT WAS PLACED ON (B)(6) 2018, AND THERE WERE NO ADVERSE REACTIONS AFTER PLACEMENT. ONE YEAR LATER, THE PATIENT REPORTED DISCOMFORT AND INFECTION WAS FOUND THROUGH EXAMINATION, SO THE IMPLANT WAS REMOVED. ADDITIONAL APPOINTMENT REQUIRED: NONE REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA.

  Patient problems: Edema; No Code Available; Unspecified Infection

  MAUDE report 10619105 ↗
• InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE IFNT510 IMPLANT LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. TOOTH SITE # 15.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10617589 ↗