OSSIOfiber® Trimmable Fixation Nail System OF2012450SRecalls & reported problems
Ossio Ltd · OSSIOfiber® Trimmable Fixation Nail System, 2.4x50mm. Package contains: 1 Implant, 1 Insertion Sleeve, 1 Bone Tamp, 1 Depth Gauge, 2 K-Wires, 1 Cannulated Drill Bit. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290017630274), received between Apr 28, 2022 and Apr 28, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 18, 2026.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method2
- Use of Device Problem2
Patient problems
- Swelling/ Edema2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 28, 2022Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method
REMOVAL SURGERY DUE TO LOCAL SWELLING AND IRRITATION 2 MONTHS FOLLOWING AN AKIN OSTEOTOMY PROCEDURE. THE SINGLE OSSIOFIBER TRIMMABLE FIXATION NAIL 2.4X50 MM THAT WAS USED IN THE AKIN OSTEOTOMY WAS REMOVED.
Patient problems: Swelling/ Edema
MAUDE report 14239978 ↗InjuryApr 28, 2022Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method
REMOVAL SURGERY DUE TO LOCAL SWELLING AND IRRITATION 2 MONTHS FOLLOWING AN AKIN OSTEOTOMY PROCEDURE. THE SINGLE OSSIOFIBER TRIMMABLE FIXATION NAIL 2.4X50 MM THAT WAS USED IN THE AKIN OSTEOTOMY WAS REMOVED.
Patient problems: Swelling/ Edema
MAUDE report 14239890 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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