OSSEOTITE® CERTAIN® IFNT410Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00844868005001), received between Sep 10, 2020 and Jun 8, 2026 — classified as 35 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #37 WAS MOBILE AND THERE WAS PAIN WHEN BITING. THE IMPLANT WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis; Pain

  MAUDE report 25432543 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 24072275 ↗
• InjuryMay 4, 2025Adverse 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. TOOTH # 19. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION.

  Patient problems: Erosion; Inflammation; Unspecified Infection

  MAUDE report 21956462 ↗
• InjuryMar 6, 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 #14 WAS REMOVED DUE TO BONE LOSS AND INFECTION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21537928 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED SINUS PERFORATION AT TOOTH LOCATION #13. THE IMPLANT WAS REMOVED.

  Patient problems: Sinus Perforation

  MAUDE report 21170262 ↗
• InjuryDec 7, 2024Adverse 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: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20873743 ↗
• InjuryJul 17, 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 FAILED FOUR (4) DAYS AFTER PLACEMENT. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 19761826 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF INCREASING PAIN AROUND THE IMPLANT AT TOOTH SITE #13. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN & INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19696657 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE 13 WAS REMOVED DUE TO PERI-IMPLANTITIS. NO IMPACT TO PATIENT, NO MEDICAL HISTORY REPORTED. ALLOGRAFT/XENOGRAFT PLACED PRIOR TO IMPLANT PLACEMENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18968122 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #31 WAS REMOVED DUE TO PERI-IMPLANTITS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15769930 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT ON TOOTH #29 WAS REMOVED DUE TO INFECTION. SYMPTOMS OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.

  Patient problems: Abscess; Inflammation; Pain; Unspecified Infection

  MAUDE report 15756561 ↗
• InjuryMay 13, 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 AT THE IMPLANT SITE.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 14394289 ↗
• 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: Inflammation; Unspecified Infection

  MAUDE report 12216584 ↗
• 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: Inflammation; Unspecified Infection

  MAUDE report 12216497 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR INDICATED INFECTION. AT THE 5-MONTH-FOLLOW-UP, HEMORRHAGE AND EVEN PYORRHEA WERE FOUND. ABSCESS IS REPORTED. TOOTH SITE # 14 (UNIVERSAL). THE IMPLANT WAS REMOVED.

  Patient problems: Abscess; Hemorrhage/Blood Loss/Bleeding; Inflammation; Unspecified Infection

  MAUDE report 12211152 ↗
• InjuryApr 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS INFECTION AT IMPLANT SITE # 28 (UNIVERSAL). THE IFNT410 IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 11607124 ↗
• InjuryNov 26, 2020Adverse 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; No Code Available; Unspecified Infection

  MAUDE report 10909329 ↗
• 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 29. INFLAMMATION WAS ALSO REPORTED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 10908699 ↗
• 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 19. INFLAMMATION WAS ALSO REPORTED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 10908599 ↗
• 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 21. INFLAMMATION WAS ALSO REPORTED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 10908525 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THEY WERE UNABLE TO ACHIEVE PRIMARY STABILITY WITH THE IFNT410 IMPLANT.

  Patient problems: No Information

  MAUDE report 10757885 ↗
• InjuryOct 8, 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) 2017, AND THERE WERE NO ADVERSE REACTIONS AFTER PLACEMENT. INFECTION WAS FOUND AFTER THREE YEARS, SO THE IMPLANT WAS REMOVED. BONE RESORPTION. ADDITIONAL APPOINTMENT REQUIRED: NONE REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA.

  Patient problems: Edema; No Code Available; Unspecified Infection

  MAUDE report 10653542 ↗
• InjuryOct 8, 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 # 5 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. PER INDICATED: THE IMPLANT WAS PLACED ON (B)(6) 2019, THE PATIENT FELT DISCOMFORTABLE AND THE IMPLANT FELL OFF. EDEMA. ADDITIONAL APPOINTMENT REQUIRED: NONE REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: NONE REPORTED.

  Patient problems: Edema; No Code Available; Unspecified Infection

  MAUDE report 10647879 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT THE IFNT410 IMPLANT AT TOOTH SITE # 20 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. THE IMPLANT WAS PLACED IN THE PATIENT ON (B)(6) 2018, AND THERE WERE NO ADVERSE REACTIONS AFTER PLACEMENT. ABNORMALITY WAS FOUND AFTER DENTURE WAS PLACED, THE PATIENT CAME HERE AND WAS EXAMINED, IMPLANT LOOSENESS WAS FOUND AND THERE WAS INFLAMMATION AROUND THE IMPLANT, SO THE IMPLANT WAS REMOVED. EDEMA.

  Patient problems: Edema; Inflammation; Unspecified Infection

  MAUDE report 10638733 ↗
• InjuryOct 5, 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 # 4 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. PER INDICATED: THE IMPLANT WAS PLACED ON (B)(6) 2019, AND THERE WERE NO ADVERSE REACTIONS AFTER PLACEMENT. THREE MONTHS LATER, THE PATIENT HAD ABNORMAL SENSATION AND CAME FOR REEXAMINATION, IT WAS FOUND THAT INFLAMMATION EXISTED AROUND THE IMPLANT AND THEREFORE THE IMPLANT WAS REMOVED. ADDITIONAL APPOINTMENT REQUIRED: NONE REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; No Code Available; Unspecified Infection

  MAUDE report 10632333 ↗