OSSEOTITE® CERTAIN® IFNT485Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00844868005049), received between Sep 8, 2020 and Jul 23, 2021 — classified as 19 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 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: Inflammation; Unspecified Infection

  MAUDE report 12220923 ↗
• InjuryJul 23, 2021Adverse 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: Abscess; Inflammation; Unspecified Infection

  MAUDE report 12216620 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR INDICATED INFECTION AT TOOTH SITE #27. SINCE THE TISSUE AROUND THE IMPLANT WAS WEAK AND ITS ABILITY TO RESIST BACTERIAL EROSION WAS WEAK, INFLAMMATION OCCURRED, LEADING TO THE IMPLANT FAILURE.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 12211407 ↗
• InjuryJul 22, 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: Inflammation; Unspecified Infection

  MAUDE report 12211032 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR INDICATED INFECTION. SINCE THE TISSUE AROUND THE IMPLANT WAS WEAK, AND ITS ABILITY TO RESIST BACTERIAL EROSION WAS WEAK, THE INFLAMMATION OCCURRED, LEADING TO THE IMPLANT FAILURE. THE IMPLANT WAS REMOVED. TOOTH SITE # 28 (UNIVERSAL).

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 12210929 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DR. INDICATED INFECTION. SINCE THE TISSUE AROUND THE IMPLANT WAS WEAK, AND ITS ABILITY TO RESIST BACTERIAL EROSION WAS WEAK, THE INFLAMMATION OCCURRED, LEADING TO THE IMPLANT FAILURE. TOOTH SITE # 29.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 12204467 ↗
• InjuryMar 19, 2021Fracture; Fracture

  THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11527303 ↗
• InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT COULD NOT BE PLACE DUE TO LACK OF PRIMARY STABILITY. THE SITE WAS GRAFTED AND LEFT FOR HEALING.

  Patient problems: No Information

  MAUDE report 11169544 ↗
• InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. PATIENT RETURNED WITH INFLAMMATION AND PAIN. THE IMPLANT WAS SUBSEQUENTLY REMOVED.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 11169444 ↗
• InjuryDec 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERI-IMPLANTITIS WITH LOSS INTEGRATION, INFLAMMATION AND EDEMA. TOOTH LOCATION #31.

  Patient problems: Edema; Inflammation; No Code Available

  MAUDE report 11100535 ↗
• InjuryDec 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Edema; Inflammation; No Code Available

  MAUDE report 11005473 ↗
• InjuryDec 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Edema; Inflammation; No Code Available

  MAUDE report 11003570 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT THE IFNT485 IMPLANT AT TOOTH SITE # 29 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. THE IMPLANT WAS PLACED ON (B)(6) 2018, AND THERE WERE NO ADVERSE REACTIONS AFTER PLACEMENT. SIX MONTHS LATER, HYPERPLASICINFLAMMATION WAS FOUND, SO THE IMPLANT WAS REMOVED. EDEMA.

  Patient problems: Edema; Inflammation; Unspecified Infection

  MAUDE report 10638627 ↗
• InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE IFNT485 IMPLANT LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. EDEMA IS ALSO REPORTED. TOOTH SITE # 28.

  Patient problems: Edema; Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 10615375 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (IFNT485) WAS REMOVED DUE TO INFECTION AT TOOTH LOCATION 14. TISSUE STRUCTURE AROUND THE IMPLANT WAS WEAK AND HAD LOW RESISTANCE TO BACTERIAL EROSION. INFLAMMATION WAS ALSO NOTED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 10518363 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (IFNT485) WAS REMOVED DUE TO BONE LOSS AT TOOTH LOCATION 30. LABIAL AND BUCCAL BONE REABSORPTION AND IMPLANT WERE EXPOSED. PAIN WAS ALSO NOTED.

  Patient problems: No Code Available; Pain

  MAUDE report 10501403 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (IFNT485) WAS REMOVED DUE TO BONE LOSS AT TOOTH LOCATION 18. LABIAL AND BUCCAL BONE REABSORPTION AND IMPLANT WERE EXPOSED. PAIN WAS ALSO NOTED.

  Patient problems: No Code Available; Pain

  MAUDE report 10501339 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (IFNT485) WAS REMOVED DUE TO BONE LOSS AT TOOTH LOCATION 19. LABIAL AND BUCCAL BONE REABSORPTION AND IMPLANT WERE EXPOSED. PAIN WAS ALSO NOTED.

  Patient problems: No Code Available; Pain

  MAUDE report 10501282 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (IFNT485) WAS REMOVED DUE TO BONE LOSS AT TOOTH LOCATION 15. PAIN WAS ALSO NOTED.

  Patient problems: No Code Available; Pain

  MAUDE report 10501240 ↗