OSSEOTITE® CERTAIN® 2 XIFOSM311Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00844868023098), received between Jan 9, 2020 and Jul 17, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 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. TOOTH SITES #26 & #14.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22536329 ↗
• InjuryJun 4, 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. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 22141208 ↗
• InjuryMar 20, 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 #32 & #42 WERE REMOVED BECAUSE IT WAS DISCOVERED 3 WEEKS FROM IMPLANT PLACEMENT DATE THAT THE PATIENT HAD A CRESTAL ABSCESS, CLINDAMICINA WAS PRESCRIBED AND IN A WEEK A CT SCAN WAS DONE AND APICAL LESIONS WERE ALSO DETECTED IN BOTH IMPLANTS. IMPLANTS WERE REMOVED DUE TO APICAL INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN. ABSCESS.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18943315 ↗
• InjuryMar 20, 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 #32 & #42 WERE REMOVED BECAUSE IT WAS DISCOVERED 3 WEEKS FROM IMPLANT PLACEMENT DATE THAT THE PATIENT HAD A CRESTAL ABSCESS, CLINDAMICINA WAS PRESCRIBED AND IN A WEEK A CT SCAN WAS DONE AND APICAL LESIONS WERE ALSO DETECTED IN BOTH IMPLANTS. IMPLANTS WERE REMOVED DUE TO APICAL INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN. ABSCESS.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18943258 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT PERFORATED ON SITE #4 AND THE IMPLANT WAS REMOVED.

  Patient problems: Bone Fracture(s)

  MAUDE report 15428462 ↗
• InjuryJun 2, 2021Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #10 LOST INTEGRATION AND WAS REMOVED DUE TO BONE LOSS. IMPLANT REMOVED AND BONE GRAFTED WITH 1/2 CC CORTICAL CANCELLOUS MIX AND 10 X 30 MEMBRANE.

  Patient problems: Osteolysis

  MAUDE report 11922029 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE XIFOSM311 IMPLANT WAS REMOVED DUE TO INFECTION. PAIN AND ABSCESS IS REPORTED. TOOTH SITE #24.

  Patient problems: Abscess; Pain; Unspecified Infection

  MAUDE report 11467463 ↗
• InjuryNov 2, 2020Adverse 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 10769707 ↗
• InjuryNov 2, 2020Adverse 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 10769693 ↗
• InjuryAug 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A LOSS OF INTEGRATION IMPLANT WITH PERI-IMPLANTITIS. THE IMPLANT IN DENTAL SITE 21 WAS REMOVED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10429848 ↗
• InjuryAug 12, 2020Adverse 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: No Code Available; Unspecified Infection

  MAUDE report 10395556 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT DID NOT ACHIEVE PRIMARY STABILITY AND WAS REMOVED. MEMBRANE AND BONE WERE PLACED FOR REGENERATION. PATIENT PRESENTED EDEMA, DEHISCENCE AND INFLAMMATION.

  Patient problems: Edema; Inflammation; Wound Dehiscence

  MAUDE report 9568205 ↗