OSSEOTITE® CERTAIN® IFNT585Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00844868005094), received between Nov 15, 2019 and Mar 7, 2025 — classified as 26 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• 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 # 31.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21546517 ↗
• InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN AILING IMPLANT WITH BLEEDING UPON PROBING. BONE LOSS WAS FOUND AROUND THE IMPLANT AT TOOTH LOCATION #4 AND THE IMPLANT WAS REMOVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Osteolysis; Unspecified Infection

  MAUDE report 21513516 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERI-IMPLANTITIS. PROCEDURE COMPLETED USING ANOTHER IMPLANT, IMPLANT REPLACED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20508824 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE IMPLANT AT TOOTH SITE #31 WAS REMOVED DUE TO PERI-IMPLANTITIS. PT STATED HAVING SYMPTOMS 2 WEEKS AFTER PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN. INFLAMMATION. ABSCESS.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20472059 ↗
• InjurySep 18, 2024Adverse 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: Erosion; Unspecified Infection

  MAUDE report 20244853 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN AND SWELLING AROUND THE IMPLANT AT TOOTH LOCATION #3. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND EDEMA.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 19623278 ↗
• InjuryFeb 10, 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: Osteolysis; Unspecified Infection

  MAUDE report 13507900 ↗
• InjuryJul 23, 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 INFECTION. TOOTH LOCATION 30. INFLAMMATION WAS ALSO NOTED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 12221266 ↗
• InjuryJul 23, 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: Abscess; Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 12221100 ↗
• InjuryJul 23, 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 INFECTION.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 12216677 ↗
• InjuryJul 23, 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 INFECTION.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 12216452 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR INDICATED INFECTION. AT THE 3-MONTH-FOLLOW-UP, HEMORRHAGE AND EVEN PYORRHEA WERE FOUND. ABSCESS WAS ALSO REPORTED. TOOTH SITE # 18 (UNIVERSAL). THE IMPLANT WAS REMOVED.

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

  MAUDE report 12210835 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS PLACED ON (B)(6) 2019. IN THE 4-MONTH-FOLLOW-UP, HEMORRHAGE AND PYORRHEA WERE FOUND, AND THE LOCAL SANITARY CONDITION WAS POOR. THE IMPLANTATION WAS FAILED. ABSCESS. TOOTH SITE # 17.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 12203102 ↗
• InjuryDec 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CLINICIAN OBSERVED PERI-IMPLANTITIS. THE PATIENT WAS IMPLANTED ON (B)(6) 2019, AND THERE WAS NO ADVERSE REACTION AFTER THE IMPLANTATION. AFTER 3 MONTHS, THE PATIENT DIDN¿T FEEL WELL. AFTER EXAMINATION, IT WAS FOUND THAT THERE WAS INFLAMMATION AROUND THE IMPLANT. THE IMPLANT WAS REMOVED. EDEMA. TOOTH LOCATION 6.

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

  MAUDE report 11094408 ↗
• InjuryNov 30, 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: Edema; Inflammation; Unspecified Infection

  MAUDE report 10920712 ↗
• InjuryNov 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THE IFNT585 IMPLANT LOST INTEGRATION DUE TO PERI IMPLANTITIS. TOOTH LOCATION # 19. THE EDEMA AND INFLAMMATION ARE REPORTED SYMPTOMS OF THE PERI IMPLANTITIS.

  Patient problems: Edema; Inflammation; Unspecified Infection

  MAUDE report 10920464 ↗
• InjuryNov 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS UNABLE TO BE PLACED INTO OSTEOTOMY; IMPLANT LACK OF PRIMARY STABILITY AND IT WAS REMOVED. TOOTH LOCATION 19.

  Patient problems: No Information

  MAUDE report 10920381 ↗
• InjuryNov 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE IFNT585 IMPLANT LOST INTEGRATION DUE TO PERI IMPLANTITIS AND WAS REMOVED. TOOTH LOCATION # 17.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 10919987 ↗
• 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 # 16 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. PER INDICATED: THE IMPLANT WAS PLACED IN THE PATIENT ON (B)(6) 2018, AND THERE WERE NO ADVERSE REACTIONS AFTER PLACEMENT. SIX MONTHS LATER, LOOSENESS WAS FOUND, AND PERI-IMPLANTITIS WAS FOUND THROUGH EXAMINATION, SO THE IMPLANT WAS REMOVED. EDEMA.

  Patient problems: Edema; No Code Available; Unspecified Infection

  MAUDE report 10653680 ↗
• 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 # 16 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. PER INDICATED: THE IMPLANT WAS PLACED IN THE PATIENT ON (B)(6) 2019, AND THERE WERE NO ADVERSE REACTIONS AFTER PLACEMENT. TEN MONTHS LATER, LOOSENESS WAS FOUND, 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 10653584 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT THE IFNT585 IMPLANT AT TOOTH SITE # 3 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. INFLAMMATION IS ALSO REPORTED.

  Patient problems: Inflammation; No Code Available; Unspecified Infection

  MAUDE report 10638124 ↗
• InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE IFNT585 IMPLANT LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. TOOTH SITE #3. INFLAMMATION IS ALSO REPORTED.

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

  MAUDE report 10613868 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT HAD AN INFECTION WITH AN ABSCESS, BLEEDING AND PYORRHEA CAUSING THE IMPLANT TO FAIL AND BE REMOVED. PATIENT WILL NOT RETURN FOR ADDITIONAL APPOINTMENTS. TOOTH #17.

  Patient problems: Abscess; No Code Available; Unspecified Infection

  MAUDE report 10513867 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ABSCESS WAS ALSO REPORTED IN ADDITION TO THE INFECTION, PYORRHEA AND BLEEDING.

  Patient problems: Abscess; No Code Available; Unspecified Infection

  MAUDE report 10507254 ↗
• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN TOOTH SITE # 14 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10343359 ↗