OSSIOfiber® Threaded Trimmable Fixation Nail System OF2084510Recalls & reported problems
Ossio Ltd · OSSIOfiber® Threaded Trimmable Fixation Nail System, H/W 4.5x70mm. Package contains: 1 Implant, and 1 Instrument pack. · 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 07290019361084), received between Oct 16, 2025 and Oct 16, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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
- Break2
Patient problems
- Loss of fracture reduction2
- Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2025Break; Break
REVISION SURGERY FOLLOWING IMPLANT BREAKAGE 8 DAYS POST METACARPAL FRACTURE FIXATION.
Patient problems: Loss of fracture reduction; Pain
MAUDE report 23308031 ↗InjuryOct 16, 2025Break; Break
REVISION SURGERY FOLLOWING IMPLANT BREAKAGE 8 DAYS POST METACARPAL FRACTURE FIXATION.
Patient problems: Loss of fracture reduction; Pain
MAUDE report 23308030 ↗
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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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