OSSEOTITE® OSS415Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00844868013204), received between Oct 1, 2019 and Nov 10, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507997 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT HAD TO BE REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9547600 ↗
• InjuryJan 3, 2020Adverse 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.

  Patient problems: Unspecified Infection

  MAUDE report 9547550 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT HAD TO BE REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9547543 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT HAD TO BE REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9547448 ↗
• InjuryJan 3, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION AND THE IMPLANT HAD TO BE REMOVED.

  Patient problems: No Information

  MAUDE report 9547111 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION AND THE IMPLANT HAD TO BE REMOVED.

  Patient problems: No Information

  MAUDE report 9547074 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS PERI-IMPLANTATIS AROUND IMPLANT OSS415. THE IMPLANT WAS REMOVED. TOOTH SITE # 13.

  Patient problems: Inflammation

  MAUDE report 9139749 ↗