OSSEOTITE® FOS511Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844868003731), received between Apr 7, 2020 and Feb 23, 2023 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH 18 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 16427979 ↗
• InjuryJan 31, 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. APICAL FOCUS PRESENTED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16273185 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BAD LOCATION FOR PROSTHESIS. 6 UPPER IMPLANTS WERE PLACED FOR REHABILITATION OF POSTERIOR SITES BUT THE IMPLANT AT TOOTH SITE 15 WAS IN BAD POSITION AND IT MADE PROSTHETIC REHABILITATION VERY COMPLICATED. IMPLANT WAS THEN REMOVED AND A NEW IMPLANT IN BETTER POSITION WAS PLACED IN THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13341833 ↗
• InjuryApr 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PROGRESSIVE PERI-IMPLANTITIS AND INFLAMMATION ON TOOTH LOCATION 46. PERI-IMPLANTITIS HAS BEEN TREATED INITIALLY ON A TRADITIONAL WAY. DOCTOR PERFORMED FLAP SURGERY AND REMOVED INFLAMMED TISSUE. PATIENT HAS BEEN RESCHEDULED FOR BONE GRAFT PLACEMENT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9932315 ↗