CORTICAL SCREW 3.5mm x 27.5mm 8010-275Recalls & reported problems
Advanced Orthopaedic Solutions, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848665019704), received between May 14, 2024 and May 15, 2024 — classified as 2 malfunctions.
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
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2024Break; Break
ON 4/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT TWO 8010-275 CORTICAL SCREWS BROKE WHILE PUTTING THEM INTO THE PATIENT. THE HEAD OF THE SCREWS WAS REMOVED, BUT THE BODIES REMAIN IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A HUMERAL NAIL PROCEDURE ON (B)(6) 2024. THE CASE WAS DELAYED BETWEEN TEN TO FIFTEEN MINUTES. THE PATIENT SUFFERED NO NEGATIVE EFFECTS.
Patient problems: Foreign Body In Patient
MAUDE report 19325766 ↗MalfunctionMay 14, 2024Break; Break
ON 4/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT TWO 8010-275 CORTICAL SCREWS BROKE WHILE PUTTING THEM INTO THE PATIENT. THE HEAD OF THE SCREWS WAS REMOVED, BUT THE BODIES REMAIN IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A HUMERAL NAIL PROCEDURE ON (B)(6) 2024. THE CASE WAS DELAYED BETWEEN TEN TO FIFTEEN MINUTES. THE PATIENT SUFFERED NO NEGATIVE EFFECTS.
Patient problems: Foreign Body In Patient
MAUDE report 19310452 ↗
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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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