AOS SOLID LOCKING LAG SCREW 10.5mm x 80mm 1094-080Recalls & reported problems
Advanced Orthopaedic Solutions, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848665015683), received between May 15, 2026 and May 15, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2026Break
IT WAS REPORTED THAT A PATIENT EXPERIENCED PAIN A FEW DAYS AFTER THE IMPLANTATION OF A TROCHANTERIC NAIL. AS A RESULT, AN X-RAY WAS TAKEN, WHICH REVEALED THAT THE LAG SCREW IN THE NAIL HAD BROKEN. THERE WAS NO SPECIFIC INCIDENT THAT LED TO THE BREAKAGE. IT WAS REPORTED THAT THE PATIENT LEFT TOWN, WHICH IS WHY NO REVISION SURGERY WAS PERFORMED.
Patient problems: Pain
MAUDE report 25186531 ↗
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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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