OSSEOTITE® CERTAIN® IFNT3210Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00844868004950), received between Oct 1, 2020 and Sep 29, 2023 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED BONE LOSS, INFECTION AND SINUS PERFORATION FOR THE IMPLANT AT TOOTH LOCATION #4. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION, NON-INTEGRATION.

  Patient problems: Osteolysis; Sinus Perforation; Unspecified Infection

  MAUDE report 17844969 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #34 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS OF THE EVENT: FISTULA, INFLAMMATION.

  Patient problems: Fistula; Osteolysis; Unspecified Infection

  MAUDE report 16521869 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR INDICATED INFECTION AT TOOTH SITE #47. THE IMPLANT WAS REMOVED DUE TO INFECTION AND PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 15588712 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DR. INDICATED INFECTION. IMPLANT REMOVED BECAUSE OF PAIN, TOOTH SITE # 31.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 14696951 ↗
• InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #7 WAS REMOVED DUE TO BECOMING INFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 12136283 ↗
• InjuryFeb 4, 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: No Code Available; Osteolysis

  MAUDE report 11279994 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO EXTENSIVE BONE LOSS AT TOOTH LOCATION 16.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 11279902 ↗
• InjuryDec 15, 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 11007867 ↗
• InjuryOct 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IFNT3210 IMPLANT AT TOOTH SITE # 13 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. EDEMA IS ALSO REPORTED.

  Patient problems: Edema; Unspecified Infection

  MAUDE report 10651010 ↗
• InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE IFNT3210 IMPLANT LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. INFLAMMATION AND EDEMA WAS ALSO REPORTED. TOOTH SITE # 28.

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

  MAUDE report 10616906 ↗