OSSEOTITE® CERTAIN® XIFNT3285Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00844868021896), received between Feb 3, 2020 and Feb 10, 2026 — classified as 37 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 37 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO MOBILITY ASSOCIATED WITH PERI-IMPLANTITIS. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT AND FOR A BONE GRAFT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24308829 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CALLED STATING THAT WHEN SHE TOOK HER LOCATER DENTURE OUT, THE IMPLANT AT TOOTH SITE #18 STUCK TO THE DENTURE AND CAME OUT AT HOME. THIS WAS LATER ASSOCIATED WITH PERI-IMPLANTITIS. THE PATIENT NOTED SLIGHT PAIN BUT PRIOR TO THE IMPLANT COMING OUT THERE WAS NO PAIN. THE SITE WAS BONE GRAFTED AND THE PATIENT IS ANTICIPATED TO RETURN FOR A NEW IMPLANT REPLACEMENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24214827 ↗
• InjuryDec 18, 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 #5 WAS REMOVED DUE TO INFECTION AND BONE LOSS. IMPLANT BECAME PAINFUL; HEALING ABUTMENT FELL OUT, AND THE IMPLANT WAS LOOSE. SYMPTOMS AS A RESULT OF THE EVENT WAS PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23843428 ↗
• InjuryDec 17, 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: Osteolysis; Unspecified Infection

  MAUDE report 23826932 ↗
• InjuryDec 8, 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 AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23736286 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT AN UNKNOWN TOOTH SITE WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT HAD PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23357438 ↗
• InjuryOct 21, 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 #36 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 23346806 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED AT TOOTH SITE #46 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED INFLAMMATION, AND ABSCESS.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 22814048 ↗
• InjuryJul 28, 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 PERI IMPLANTITIS, TOOTH SITE: 6.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22637459 ↗
• InjuryMay 10, 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. TOOTH # 4.

  Patient problems: Osteolysis

  MAUDE report 21999469 ↗
• InjuryMar 14, 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. PATIENT WALKED INTO THE OFFICE WITH THE IMPLANT IN HAND. PATIENT STATES "THE IMPLANT JUST FELL OUT." THE SITE WAS CLEANED OUT VIA DEBRIDEMENT. TOOTH #7. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21604913 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME INTO THE OFFICE FOR AN INTEGRATION CHECK AND WHEN TORQUE WAS APPLIED TO THE IMPLANT AT TOOTH LOCATION #10, THE WHOLE IMPLANT SPUN AND CAME OUT. THE IMPLANT FAILED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21527030 ↗
• InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #22 & #27 WERE REMOVED DUE TO BONE LOSS. PATIENT RETURNED FOR EVALUATION OF IMPLANTS AND BONE LOSS WAS DISCOVERED.

  Patient problems: Osteolysis

  MAUDE report 20217001 ↗
• InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #22 & #27 WERE REMOVED DUE TO BONE LOSS. PATIENT RETURNED FOR EVALUATION OF IMPLANTS AND BONE LOSS WAS DISCOVERED.

  Patient problems: Osteolysis

  MAUDE report 20216942 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE DENTURE WAS NOT ADJUSTED CORRECTLY, CAUSING THE IMPLANT AT TOOTH LOCATION # 7 TO BECOME MOBILE. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain

  MAUDE report 19843187 ↗
• InjuryApr 30, 2024Adverse 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.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19217360 ↗
• InjuryJan 30, 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: Osteolysis; Pain; Unspecified Infection

  MAUDE report 18605241 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED IMPLANTS PLACED AND BURIED. SUTURES REMOVED AND ONE WEEK LATER AND ISSUES NOTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT IMPLANT TOOTH SITES #29 AND 30. PATIENT RETURNED ONE WEEK LATER WITH COMPLAINTS OF PAIN AND SWELLING. NOTED TO HAVE PARULIS HEAL # 29. FLAP REFLECTED AND PUS/BONE LOSS NOTED. #29 AND #30 IMPLANTS. BOTH IMPLANTS WERE REMOVED AND CURETTED OSTOMY SITES. ACUTE OSTEOMYELITIS NOTED.

  Patient problems: Unspecified Infection

  MAUDE report 18333243 ↗
• InjuryDec 1, 2023Adverse 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: Osteolysis; Unspecified Infection

  MAUDE report 18246475 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED 1 DENTAL IMPLANT WAS REMOVED AT TOOTH SITE #11 DUE TO A PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 18140284 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #16 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18071618 ↗
• InjurySep 28, 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 PERI-IMPLANTITIS. INFLAMMATION AND PAIN AS A CONSEQUENCE OF THE EVENT. TOOTH LOCATION 25.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 17833667 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES # 21, 23 AND 13 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17228693 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES # 21, 23 AND 13 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17228658 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH #15 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 16550767 ↗