OSSIOfiber® Trimmable Fixation Nail System, Cannulated OF2053050SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07290017630137), received between Feb 6, 2023 and Nov 30, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (6 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 18, 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 30, 2025Use of Device Problem; Use of Device Problem

  IMPLANT REMOVAL DUE TO LOCAL TOE SWELLING 2 MONTHS FOLLOWING A HAMMERTOE CORRECTION PROCEDURE. CASE RESOLVED WITH NO ADDITIONAL INTERVENTION.

  Patient problems: Swelling/ Edema

  MAUDE report 23677021 ↗
• InjuryNov 30, 2025Use of Device Problem; Use of Device Problem

  IMPLANT REMOVAL DUE TO LOCAL TOE SWELLING 2 MONTHS FOLLOWING A HAMMERTOE CORRECTION PROCEDURE. CASE RESOLVED WITH NO ADDITIONAL INTERVENTION.

  Patient problems: Swelling/ Edema

  MAUDE report 23677020 ↗
• InjuryNov 30, 2025Use of Device Problem; Use of Device Problem

  IMPLANT REMOVAL DUE TO LOCAL TOE SWELLING 2 MONTHS FOLLOWING A HAMMERTOE CORRECTION PROCEDURE. CASE RESOLVED WITH NO ADDITIONAL INTERVENTION.

  Patient problems: Swelling/ Edema

  MAUDE report 23677018 ↗
• InjuryNov 30, 2025Use of Device Problem; Use of Device Problem

  IMPLANT REMOVAL DUE TO LOCAL TOE SWELLING 2 MONTHS FOLLOWING A HAMMERTOE CORRECTION PROCEDURE. CASE RESOLVED WITH NO ADDITIONAL INTERVENTION.

  Patient problems: Swelling/ Edema

  MAUDE report 23677017 ↗
• InjuryNov 30, 2025Use of Device Problem; Use of Device Problem

  IMPLANT REMOVAL DUE TO LOCAL TOE SWELLING 2 MONTHS FOLLOWING A HAMMERTOE CORRECTION PROCEDURE. CASE RESOLVED WITH NO ADDITIONAL INTERVENTION.

  Patient problems: Swelling/ Edema

  MAUDE report 23677012 ↗
• InjuryNov 30, 2025Use of Device Problem; Use of Device Problem

  IMPLANT REMOVAL DUE TO LOCAL TOE SWELLING 2 MONTHS FOLLOWING A HAMMERTOE CORRECTION PROCEDURE. CASE RESOLVED WITH NO ADDITIONAL INTERVENTION.

  Patient problems: Swelling/ Edema

  MAUDE report 23677011 ↗
• InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL SURGERY 3.5 MONTHS POST-SURGERY DUE TO LOCAL DRAINAGE AT THE INSERTION POINT. THE IMPLANT WAS ORIGINALLY USED PERCUTANEOUSLY, INSERTED THROUGH THE TIP OF THE TOE, AS PART OF A REVISION OF A HAMMERTOE.

  Patient problems: Fluid Discharge

  MAUDE report 16303179 ↗
• InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL SURGERY 3.5 MONTHS POST-SURGERY DUE TO LOCAL DRAINAGE AT THE INSERTION POINT. THE IMPLANT WAS ORIGINALLY USED PERCUTANEOUSLY, INSERTED THROUGH THE TIP OF THE TOE, AS PART OF A REVISION OF A HAMMERTOE.

  Patient problems: Fluid Discharge

  MAUDE report 16303030 ↗