OSSIOfiber® Hammertoe Fixation System OF20025160Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07290017630076), received between Jan 13, 2021 and Oct 21, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  REVISION PROCEDURE ABOUT 1 MONTH FOLLOWING HAMMERTOE FIXATION SURGERY DUE TO LOCAL INFLAMMATORY REACTION IN A PATIENT WITH RHEUMATOID ARTHRITIS.

  Patient problems: Local Reaction

  MAUDE report 23346201 ↗
• InjuryOct 21, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  REVISION PROCEDURE ABOUT 1 MONTH FOLLOWING HAMMERTOE FIXATION SURGERY DUE TO LOCAL INFLAMMATORY REACTION IN A PATIENT WITH RHEUMATOID ARTHRITIS.

  Patient problems: Local Reaction

  MAUDE report 23346200 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON OBSERVED SWELLING IN THE PATIENT'S FOOT AT 3 MONTH FOLLOW-UP AND REMOVED THE TWO OSSIOFIBER HAMMERTOE IMPLANTS. SURGEON REPORTED BOTH PIP FUSION SHOWED NON-UNION, WITH ONE IMPLANT PUSHED OUT AND ONE IMPLANT BROKEN IN HALF. SURGEON DRILLED OUT THE IMPLANTS AND SENT SAMPLES FOR CULTURE. HE SUBSEQUENTLY FIXATED THE TOES.

  Patient problems: Swelling/ Edema

  MAUDE report 11160615 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON OBSERVED SWELLING IN THE PATIENT'S FOOT AT 3 MONTH FOLLOW-UP AND REMOVED THE TWO OSSIOFIBER HAMMERTOE IMPLANTS. SURGEON REPORTED BOTH PIP FUSION SHOWED NON-UNION, WITH ONE IMPLANT PUSHED OUT AND ONE IMPLANT BROKEN IN HALF. SURGEON DRILLED OUT THE IMPLANTS AND SENT SAMPLES FOR CULTURE. HE SUBSEQUENTLY FIXATED THE TOES.

  Patient problems: Swelling/ Edema

  MAUDE report 11160571 ↗