OSSIOfiber® Trimmable Fixation Nail System OF2012430SRecalls & reported problems
Ossio Ltd · OSSIOfiber® Trimmable Fixation Nail System, 2.4x30mm. Package contains: 2 Implants, 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 07290017630267), received between Sep 22, 2021 and Sep 22, 2021 — 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
- Malunion of Bone2
- Swelling/ Edema2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2021Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method
REMOVAL SURGERY DUE TO LOCAL TOE SWELLING AND MISALIGNMENT IN THE PIP JOINT 10 WEEKS FOLLOWING A PIP AND DIP FUSION WITH ONE OSSIOFIBER TRIMMABLE FIXATION NAIL 2.4X30 MM. TOE WAS SUBSEQUENTLY SUCCESSFULLY ALIGNED AND FIXATED.
Patient problems: Malunion of Bone; Swelling/ Edema
MAUDE report 12515891 ↗InjurySep 22, 2021Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method
REMOVAL SURGERY DUE TO LOCAL TOE SWELLING AND MISALIGNMENT IN THE PIP JOINT 10 WEEKS FOLLOWING A PIP AND DIP FUSION WITH ONE OSSIOFIBER TRIMMABLE FIXATION NAIL 2.4X30 MM. TOE WAS SUBSEQUENTLY SUCCESSFULLY ALIGNED AND FIXATED.
Patient problems: Malunion of Bone; Swelling/ Edema
MAUDE report 12515845 ↗
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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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