OSSEOTITE® CERTAIN® IFNT413Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00844868005025), received between Sep 1, 2020 and Mar 6, 2026 — classified as 13 injuries.

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

• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #5 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24531964 ↗
• InjuryNov 17, 2025Adverse 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: Unspecified Infection

  MAUDE report 23577271 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23568203 ↗
• InjuryMar 7, 2025Adverse 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: Inflammation; Pain; Unspecified Infection

  MAUDE report 21546743 ↗
• 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 INFECTION. PATIENT PRESENTED TWO WEEKS POST OP WITH INFLAMMATION AND PURULENCE. COURSE OF AMOX 500, TIME 21, THREE TIMES A DAY. NO IMPROVEMENT, REMOVED. TOOTH 29. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA, INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 21546607 ↗
• InjuryNov 7, 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 INFECTION AND BONE LOSS AT THE IMPLANT SITE.

  Patient problems: Abscess; Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 15746187 ↗
• InjuryOct 9, 2021Adverse 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12602546 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS DIAGNOSED WITH BRONJ. IT WAS REPORTED THAT THE IFNT413 IMPLANT WAS REMOVED DUE TO INFECTION AND BONE LOSS. ABSCESS, EDEMA, DEHISCENCE, INFLAMMATION AND PAIN ARE REPORTED AS SYMPTOMS. SITE WAS GRAFTED PRIOR TO ORIGINAL IMPLANT PLACEMENT WITH ALLOGRAFT, XENOGRAFT AND AUTOGENOUS BONE GRAFT.

  Patient problems: Abscess; Inflammation; Osteolysis; Pain; Unspecified Infection; Wound Dehiscence

  MAUDE report 11790250 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS DIAGNOSED WITH BRONJ. IT WAS REPORTED THAT THE IFNT413 IMPLANT WAS REMOVED DUE TO INFECTION AND BONE LOSS. ABSCESS, EDEMA, DEHISCENCE, INFLAMMATION AND PAIN ARE REPORTED AS SYMPTOMS. SITE WAS GRAFTED PRIOR TO ORIGINAL IMPLANT PLACEMENT WITH ALLOGRAFT, XENOGRAFT AND AUTOGENOUS BONE GRAFT.

  Patient problems: Abscess; Osteolysis; Pain; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 11789640 ↗
• InjuryJan 27, 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: Pain

  MAUDE report 11235784 ↗
• InjuryNov 2, 2020Fracture; Fracture

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

  Patient problems: No Information

  MAUDE report 10774897 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (IFNT413) WAS REMOVED DUE TO PERI-IMPLANTITIS AT TOOTH LOCATION 11. REDNESS, SWELLING OF MUCOSA AND LOOSENING OF THE IMPLANT WAS REPORTED TO CAUSE THE IMPLANT FAILURE. INFLAMMATION WAS ALSO NOTED.

  Patient problems: Inflammation; No Code Available; Swelling; Unspecified Infection

  MAUDE report 10518310 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CLINICIAN INDICATED INFECTION, PERI-IMPLANTITIS. THE IMPLANT WAS PLACED IN THE PATIENT ON (B)(6) 2018, AT TOOTH LOCATION 25 AND AFTER 6 MONTHS, REEXAMINATION REVEALED THAT PERI-IMPLANTITIS OCCURRED, MUCOSA WAS RED AND SWOLLEN, THE IMPLANT FAILED. INFLAMMATION.

  Patient problems: Inflammation; No Code Available; Unspecified Infection

  MAUDE report 10480746 ↗