OSSEOTITE® CERTAIN® XIFNT3215Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00844868021919), received between Sep 6, 2019 and Jan 26, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED FOR AN IMPLANT CHECK AND PERI APICAL RADIOLUCENCY WAS NOTICED AROUND THE IMPLANT AT TOOTH SITE #26, EVEN THOUGH THE IMPLANT WAS INTEGRATED. THE IMPLANT WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 24176768 ↗
• InjuryDec 30, 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 PERIIMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, BONE LOSS. TOOTH SITE: 5.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 23923726 ↗
• InjuryDec 30, 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 PERIIMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, BONE LOSS. TOOTH SITE: 7.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 23923724 ↗
• InjuryDec 29, 2025Adverse 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: Pain

  MAUDE report 23917286 ↗
• InjuryOct 31, 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 MOBILE AND FAILED. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23437657 ↗
• InjuryFeb 18, 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 INFECTION AND BONE LOSS. IMPLANT PLACED ANT MANDIBLE 3 1/2 WEEKS LATER RETURNED WITH PAIN, SWELLING, ABSCESS AND PARULIS. OPENED SITE AND IMPLANT LOOSE WITH BONE LOSS. ADDITIONAL APPOINTMENT WAS REQUIRED FOR IMPLANT REPLACEMENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21396016 ↗
• InjuryNov 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ANTERIOR BONE LOSS AT IMPLANTS TOOTH SITES #23 AND 25, WITH ABOUT 35% EXPOSURE. THEREFORE, THE IMPLANTS WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 18205040 ↗
• InjuryNov 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ANTERIOR BONE LOSS AT IMPLANTS TOOTH SITES #23 AND 25, WITH ABOUT 35% EXPOSURE. THEREFORE, THE IMPLANTS WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 18205024 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #42 AND #32 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18071300 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #42 AND #32 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18065443 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION WITH ABSCESS AT IMPLANT TOOTH SITE #10 (CAPTURE IN (B)(4)). ANTIBIOTICS WERE GIVEN WITH NO IMPROVEMENT. THE INFECTION WAS STILL PRESENT, AND IMPLANT WAS REMOVED ONE WEEK AFTER ANTIBIOTIC ADMINISTRATION.

  Patient problems: Atrial Flutter; Unspecified Infection

  MAUDE report 17981280 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION WITH ABSCESS AT IMPLANT TOOTH SITE #10. ANTIBIOTICS WERE GIVEN WITH NO IMPROVEMENT. THE INFECTION WAS STILL PRESENT, AND IMPLANT WAS REMOVED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 17733474 ↗
• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT PATIENT DECIDED TO GO WITH A FIXED HYBRID AND IMPLANT WASN'T IN CORRECT POSITION, TOOTH 24. IMPLANT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17423738 ↗
• InjuryJun 12, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE HEX OF THE IMPLANT AT TOOTH LOCATION #25 WAS STRIPPED/DAMAGED AT THE TIME OF PLACEMENT AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107858 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF CONTINUOUS, CONSTANT PAIN, BURNING SENSATION. INFECTION WAS NOTED AT TIME OF REMOVAL.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16563860 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF CONTINUOUS, CONSTANT PAIN, BURNING SENSATION. INFECTION WAS NOTED AT TIME OF REMOVAL.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16563832 ↗
• InjuryMar 10, 2023Adverse 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. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, EDEMA, INFLAMMATION AND PAIN. TOOTH SITE 7 (FDI). THE SITE WAS GRAFTED WITH ALLOGRAFT TOGETHER WITH ORIGINAL IMPLANT PLACEMENT.

  Patient problems: Abscess; Inflammation; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16522031 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED PERI-IMPLANTITIS, SWELLING AND PAIN AROUND THE IMPLANT AT TOOTH LOCATION #26. THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 15996835 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT PRIMARY STABILITY WAS NOT ACHIEVED WITH THE IMPLANT IN TOOTH POSITION # 41 (FDI).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565467 ↗
• InjuryJul 6, 2021Adverse 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: Inflammation; Pain

  MAUDE report 12125751 ↗
• InjuryJun 24, 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: Osteolysis; Pain; Unspecified Infection

  MAUDE report 12062466 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE XIFNT3215 IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH LOCATION # 25.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 10898568 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED RIGHT AFTER PLACEMENT DUE TO POOR BONE QUALITY. ADDITIONAL APPOINTMENT WOULD BE REQUIRED: O PLACE A NEW IMPLANT.

  Patient problems: No Information

  MAUDE report 10716752 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED FROM TOOTH SITE 13 DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9592347 ↗
• InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. AS A RESULT, THE IMPLANT HAD TO BE REMOVED FROM TOOTH SITE 26.

  Patient problems: Unspecified Infection

  MAUDE report 9298348 ↗