OSSEOTITE® CERTAIN® XIFNT3211Recalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 00844868021933), received between Sep 6, 2019 and Sep 30, 2026 — classified as 111 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 113 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 24.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50943971 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  The patient reported that the abutment came off approximately one week after placement. The implant subsequently failed to integrate, with an infection and abscess present at tooth #7.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 50297402 ↗
• InjuryJul 10, 2026Mechanical Problem; Failure to Osseointegrate

  IT WAS REPORTED THAT THREE IMPLANTS WERE REMOVED DUE TO HAVING DAMAGED THREADS AND NON-INTEGRATION. ON THE DAY OF PLACEMENT, DOCTOR FELT THAT THE SPIRALS DIDN'T SEEM RIGHT. EDEMA AND INFLAMMATION WERE REPORTED AS A CONSEQUENCE.

  Patient problems: Inflammation; Swelling/ Edema

  MAUDE report 25776749 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS AND INFECTION. PAIN FELT (B)(6) 2025, EXAM REVEALED MINOR SWELLING AT #25 IMPLANT SITE ALONG WITH EXUDATE. X-RAY TAKEN REVEALING BONE LOSS OF #25 IMPLANT.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 24628475 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #36 AND #37 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24536283 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #36 AND #37 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24536165 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #35 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24458147 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #42 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24085744 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #5 WAS REMOVED DUE TO BONE LOSS. AN ADDITIONAL APPOINTMENT WAS REQUIRED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 24027996 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #25 WAS REMOVED DUE TO GINGIVA, ASSOCIATED WITH BONE LOSS. THE IMPLANT COULD NOT BE REPLACED DUE TO THE THIN RIDGE AND THE AMOUNT OF BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis

  MAUDE report 23993046 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #7, AND #12 WERE REMOVED DUE TO INFECTION. PATIENT PRESENTED FOR FOLLOW UP DUE TO PAIN, PATIENT HAD INFECTION AND THE IMPLANTS WERE LOOSE. SYMPTOMS AS A RESULT OF THE EVENT WAS ABSCESS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 23871053 ↗
• InjuryDec 3, 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: Osteomyelitis; Pain

  MAUDE report 23708024 ↗
• InjuryDec 3, 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: Osteomyelitis; Pain

  MAUDE report 23707908 ↗
• InjuryNov 10, 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 INFECTION. AN ADDITIONAL APPOINTMENT WAS ANTICIPATED TO REPLACE THE IMPLANT APPROXIMATELY FOUR MONTHS FROM THE IMPLANT REMOVAL PROCEDURE DATE.

  Patient problems: Unspecified Infection

  MAUDE report 23512635 ↗
• InjuryNov 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 23508535 ↗
• InjuryOct 15, 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 problems: Osteolysis; Unspecified Infection

  MAUDE report 23302182 ↗
• InjuryAug 28, 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 INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22910953 ↗
• InjuryAug 7, 2025Adverse 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22737453 ↗
• InjuryAug 4, 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 PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22698296 ↗
• InjuryJul 28, 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 PERI-IMPLANTITIS. UNKNOWN TOOTH SITE. SYMPTOMS REPORTED ON THE PATIENT ARE INFLAMMATION, EDEMA, AND ABSCESS.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 22626946 ↗
• InjuryJul 24, 2025Fracture; Fracture

  IT WAS REPORTED A FRACTURE OF THE LOWER PART OF THE IMPLANT OBSERVED DURING THE CLINICAL PROCEDURE. THE PROCESS WAS COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585647 ↗
• InjuryJul 14, 2025Fracture; Fracture

  IT WAS REPORTED A FRACTURE OF THE UPPER PART OF THE IMPLANT AT TOOTH SITE 26. THE PROCESS WAS COMPLETED WITH ANOTHER IMPLANT. IMPLANT MOBILITY WAS ALSO REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22492374 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #6, #8 AND #9 WERE REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 22348218 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #6, #8 AND #9 WERE REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 22347790 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #6, #8 AND #9 WERE REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 22347742 ↗