OSSEOTITE® FOS413Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00844868003625), received between Dec 11, 2019 and Nov 17, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2022Loss 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 #8 DEVELOPED PERI-IMPLANTITIS AND WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15820650 ↗
• InjuryMay 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT FAILED DUE TO SIGNIFICANT INFECTION AT IMPLANT SITE AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION, PAIN AND INFECTION.

  Patient problems: Abscess; Inflammation; Pain; Unspecified Infection

  MAUDE report 11861651 ↗
• InjuryMar 25, 2020Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pain

  MAUDE report 9878370 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS UNABLE TO BE PLACED DUE TO LACK OF PRIMARY STABILITY.

  Patient problems: No Information

  MAUDE report 9577429 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT PRIMARY STABILITY WAS NOT ACHIEVED FOR IMPLANT FOS413 DUE TO SOFT BONE.

  Patient problems: No Code Available

  MAUDE report 9457561 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT PRIMARY STABILITY WAS NOT ACHIEVED FOR IMPLANT FOS413 DUE TO SOFT BONE.

  Patient problems: No Information

  MAUDE report 9457468 ↗
• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT FOS413 IN DENTAL SITE 5 HAD TO BE REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9449916 ↗