OSSEOTITE® 2 XFOS565Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844868024095), received between Feb 26, 2020 and Jul 1, 2024 — 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.

• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN TOOTH SITE #47 WAS REMOVED AFTER SIGNIFICANT BONE LOSS AND PERI-IMPLANTITIS WAS FOUND. NO ADDITIONAL APPOINTMENT REQUIRED. NO PATIENT IMPACT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19641913 ↗
• InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER TWO (2) YEARS, THE PATIENT CAME BACK TO CHECK OUT THE IMPLANT'S CONDITION AT TOOTH LOCATION #3 AND BONE LOSS WAS NOTED. THE IMPLANT AS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17252410 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR WAS UNABLE TO PLACE THE IMPLANT INTO THE PATIENT'S OSTEOTOMY DUE TO LACK OF PRIMARY STABILITY. THE DOCTOR ALSO REPORTED THAT ANOTHER IMPLANT WAS NOT PLACED AND THAT HE IS WAITING FOR ADEQUATE TIME FOR BONE REGENERATION.

  Patient problems: No Information

  MAUDE report 9757670 ↗