OSSIOfiber® Trimmable Fixation Nail System, Cannulated OF2054100SRecalls & reported problems
Ossio Ltd · OSSIOfiber® Trimmable Fixation Nail System, 4.0x100mm, Cannulated. Package contains: 1 Implant, and 1 instrument pack. · Class 1 · Implant
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 07290019361022), received between Jan 16, 2025 and Jan 16, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (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.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem2
Patient problems
- Loss of fracture reduction2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 16, 2025Use of Device Problem; Use of Device Problem
REVISION SURGERY FOLLOWING IMPLANT BREAKAGE 2 WEEKS POST CLAVICLE FIXATION SURGERY.
Patient problems: Loss of fracture reduction
MAUDE report 21168001 ↗InjuryJan 16, 2025Use of Device Problem; Use of Device Problem
REVISION SURGERY FOLLOWING IMPLANT BREAKAGE 2 WEEKS POST CLAVICLE FIXATION SURGERY.
Patient problems: Loss of fracture reduction
MAUDE report 21167996 ↗
Other Orthopedic Tray devices
- Medline Industries, Inc. DYNJ900718CMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. DYNJ905330BMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. DYNJ17452SMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. DYNJ21826RMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. CDS780119VMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. DYNJ902473LMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. DYNJ906893DMedline Industries, Inc. · Orthopedic tray4 recalls2 reports
- Medline Industries, Inc. DYNJ909505AMedline Industries, Inc. · Orthopedic tray4 recalls1 report
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.
How reports and recalls are matched · Editorial policy · Report an error on this page