OSSEOTITE® CERTAIN® 2 XIFOSM313Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844868023104), received between Sep 20, 2019 and Jun 16, 2022 — classified as 3 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 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 PERI-IMPLANTITIS AT THE SITE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 14712454 ↗
• InjuryDec 20, 2019Adverse 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. THE PATIENT ALSO HAD AN ABSCESS. TOOTH LOCATION 10.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 9507130 ↗
• InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE IMPLANT XIFOSM313 WAS REMOVED DUE TO INFECTION. AN ABSCESS WAS ALSO NOTED. TOOTH SITE # 25.

  Patient problems: Unspecified Infection

  MAUDE report 9099347 ↗