OSSEOTITE® CERTAIN® XIFNT610Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00844868022053), received between Jan 27, 2020 and May 21, 2026 — classified as 25 injuries, 1 malfunction.

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

• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION AND BONE LOSS. PATIENT HAD PRESENTED TO OFFICE SEVERAL TIMES IMPLANT INFECTED, DEBRIDED AREA, HAD ALLOGRAFT PACKED. UPON IMPLANT BEING REMOVED, IMPLANT WAS EXPOSED. NOTED ABSCESS.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 25247484 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO BONE LOSS. BONE LOSS IMPLANT REMOVED & BONE GRAFT COMPLETED.

  Patient problems: Osteolysis

  MAUDE report 24474330 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO A CLINIC WITH PURULENCE SURROUNDING A RESTORED IMPLANT AT TOOTH SITE #31. DURING AN EXAMINATION OF THIS TOOTH SITE, BONE LOSS AND INFECTION WERE DISCOVERED. THE IMPLANT WAS REMOVED WITH SITE DEBRIDEMENT. AFTER FOUR MONTHS OF HEALING, AN IMPLANT REPLACEMENT IS EXPECTED. SYMPTOMS RELATED TO EVENT: INFLAMMATION, PAIN AND SWELLING.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24086204 ↗
• 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 23720414 ↗
• InjuryNov 11, 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 #30 WAS REMOVED DUE TO BONE LOSS. BONE LOSS CIRCUMFERENTIALLY.

  Patient problems: Osteolysis

  MAUDE report 23523140 ↗
• InjuryAug 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANTS LOCATED IN POSITIONS #26 & #22 FAILED DUE TO SEVERE PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22823798 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 16, 15, 26 WERE REMOVED DUE TO SEVERE PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21983074 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 16, 15, 26 WERE REMOVED DUE TO SEVERE PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21983033 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED FOR PERI-IMPLANTITIS. TOOTH #15. DISCOVERED DURING TORQUE TEST OF IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, LOSS OF INTEGRATION, BONE LOSS.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21909377 ↗
• InjuryDec 13, 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 #14 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT PLACEMENT W/ SINUS AUGMENTATION PERFORMED 2 MONTHS POST TOOTH EXTRACTION. PATIENT PRESENTED IN OFFICE FOR 3 MONTH PA - SIGNS OF IMPLANT FAILURE SHOWN THROUGH RADIOGRAPHY IMAGE - UNCOVER OF IMPLANT PERFORMED ON (B)(6), 2024, IMPLANT WAS THEN REMOVED AND THE SITE WAS GRAFTED. PROCEDURE WAS NOT COMPLETED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20923797 ↗
• InjuryAug 12, 2024Adverse 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: Pain

  MAUDE report 19967765 ↗
• InjuryJul 9, 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: Pain

  MAUDE report 19705368 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EARLY ACUTE PERI-IMPLANTIS, NON-INTEGRATION, ROG. TEETH LOCATION: 10, 34, 31, 35. BONE DENSITY TYPE: III.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18221120 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: Pain

  MAUDE report 18162289 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH #3.

  Patient problems: Unspecified Infection

  MAUDE report 17627194 ↗
• InjuryJun 8, 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, ALSO REPORTED AS ABSCESS, AT IMPLANT TOOTH #18 WITH ASSOCIATED BONE LOSS. IMPLANT SALVAGE NOT POSSIBLE; THEREFORE, IT WAS REMOVED.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 17087812 ↗
• MalfunctionMay 6, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE INTERNAL HEX OF THE IMPLANT IS DAMAGED. THE IMPLANT WILL NOT BE REMOVED. THE DOCTOR IS USING A NEW STOCK ABUTMENT TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883040 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT LOST INTEGRATION DUE TO PERI-IMPLANTITIS AT THE IMPLANT SITE AND WAS REMOVED.

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 15896151 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE PATIENT REQUESTED THAT THE CLINICIAN REMOVE THE IMPLANT. TOOTH SITE #30 (UNIVERSAL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15813479 ↗
• InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A RADIOGRAPHIC IMAGE REVEALED AN INFECTION. USED FORCEPS TO REMOVE IMPLANT. TOOTH SITE #30 (UNIVERSAL).

  Patient problems: Unspecified Infection

  MAUDE report 13667514 ↗
• InjuryFeb 17, 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 AN INFECTION AT THE SITE. PATIENT WILL RETURN FOR FOLLOW UP APPOINTMENT. TOOTH #19.

  Patient problems: Unspecified Infection

  MAUDE report 13549608 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS NO STABILITY AT TOOTH SITE #S 31 & 13. THE IMPLANTS WERE REMOVED. THE PATIENT IS RETURNING FOR FUTURE IMPLANT PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12673514 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT THAT WAS PLACED IN SITE 18 (UNIVERSAL) WAS REMOVED DUE TO PERI-IMPLANTITIS CAUSING LOSS OF INTEGRATION. SITE WAS GRAFTED WITH ALLOGRAFT PRIOR TO IMPLANT PLACEMENT. NOTED PAIN AT IMPLANT SITE AS A RESULT OF THE EVENT. NO FURTHER INJURY TO THE PATIENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 12298112 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE #20 WERE UNABLE TO GAIN PRIMARY STABILITY AND WERE REMOVED. THE SITE WAS GRAFTED AND THE PATIENT WILL RETURN AT A LATER DATE TO REPLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12240706 ↗
• InjuryOct 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (XIFNT610) WAS REMOVED DUE TO INFECTION/ PERI-IMPLANTITIS. DOCTOR ATTEMPTED TO SAVE THE IMPLANT AND SITE AREA WAS FLAPPED AND CLEANED OUT; PATIENT WAS PLACED UNDER MEDICATION; HOWEVER, THE IMPLANT COULD NOT BE SAVE AND WAS FINALLY REMOVED. SITE WAS GRAFTED. PAIN, INFLAMMATION, AND EDEMA WERE ALSO REPORTED. TOOTH LOCATION 3.

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

  MAUDE report 10714758 ↗