OSSEOTITE® CERTAIN® XIFNT410Recalls & reported problems

Summary

The FDA's MAUDE database contains 194 adverse event reports that list this exact device (DI 00844868021957), received between Oct 18, 2019 and Sep 30, 2026 — classified as 186 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (18 reports).

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 194 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  It was reported loss of integration due to Peri-implantitis at tooth site 21.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50944161 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the dental implant at Tooth Location 21 failed due to peri-implantitis. Pain and inflammation were also reported.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 50051765 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #8 WAS PLACED WITH HYBRID PLANNED. THE IMPLANT DEVELOPED PERI-IMPLANTITIS AND HAD TO BE REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25472953 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 25448212 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #16 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 25448015 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25447209 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANTS AT TOOTH SITE #45-46 WERE REMOVED DUE TO PERIIMPLANTITIS . PATIENT REFERRED PAIN. NEW IMPLANTS WILL BE PLACED AFTER REGENERATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25122833 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANTS AT TOOTH SITE #45-46 WERE REMOVED DUE TO PERI-IMPLANTITIS . PATIENT REFERRED PAIN. NEW IMPLANTS WILL BE PLACED AFTER REGENERATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25122495 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO INFECTION. IMMEDIATE IMPLANT WAS PLACED WITH ALLOGRAFT AT 20 N CM AND COVER SCREW WAS PLACED. AT THREE WEEKS THERE WAS A SUTURE REMOVAL APPOINTMENT. THE IMPLANT IMPLANT WAS LOOSE AND WAS REMOVED WITH TWEEZERS. THE IMPLANT SITE WAS DEGRANULATED AND A RIDGE PRESERVATION WAS COMPLETED WITH PTFE MEMBRANE. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA AND INFLAMMATION.

  Patient problems: Inflammation; Swelling/ Edema; Unspecified Infection

  MAUDE report 25000501 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO A PERI-IMPLANTITIS PATIENT SUFFERED FROM PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24963945 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #25 WAS REMOVED DUE TO BONE LOSS AFTER SINUS LIFT. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: Osteolysis

  MAUDE report 24560272 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #21 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24536528 ↗
• MalfunctionFeb 13, 2026Mechanical Problem

  DOCTOR REPORTS WHEN TRYING TO PLACE THE IMPLANT AT TOOTH LOCATION 46, THE DRIVER SPINS FREELY AND DISENGAGES FROM THE IMPLANT. ANOTHER IMPLANT WAS PLACED DURING THE SAME PROCEDURE USING THE SAME DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24330373 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24328269 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND SUPPURATION.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 24306075 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI IMPLANTITIS. PATIENT PRESENTED FOR INTEGRATION CHECK IMPLANT SITE 10. BONE LOSS ON PANO. PATIENT COMPLAINTS OF PAIN. TISSUE IS RED. IMPLANT REMOVED. SITE WAS BONE GRAFTED AND PATIENT WILL RETURN IN 4 MONTHS FOR REPLACEMENT. NOTED PAIN AND INFLAMMATION. WILL RETURN IN 4 MONTHS FROM REPLACEMENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24193468 ↗
• InjuryJan 16, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24091503 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24085190 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24015328 ↗
• InjuryDec 20, 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 #23 WAS REMOVED DUE TO BONE LOSS. PATIENT EXPERIENCED INFLAMMATION.

  Patient problems: Inflammation; Osteolysis

  MAUDE report 23858503 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 45 WAS REMOVED DUE TO PERI-IMPLANTITIS. AFTER 3-4 WEEKS OF CROWN PLACEMENT, PATIENT CAME TO CLINICIAN INDICATING CROWN MOBILITY, BUT DOCTOR NOTICED THAT IT WAS THE IMPLANT INSTEAD. PATIENT REFERRED PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23756878 ↗
• InjuryDec 5, 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 BONE LOSS. NO OTHER IMPLANT WAS PLACED DURING THE SAME PROCEDURE.

  Patient problems: Osteolysis

  MAUDE report 23733325 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH OTHER IMPLANTS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23720501 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH OTHER IMPLANTS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23720381 ↗
• MalfunctionNov 10, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510696 ↗