MIS Beveled Screw SF4058Recalls & reported problems
Treace Medical Concepts, Inc. · Beveled Screw · 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 00810111223041), received between May 30, 2025 and May 30, 2025 — 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
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2025Break; Break
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2024, TWO BROKEN SCREWS WERE DISCOVERED DURING A POST OPERATIVE FOLLOW-UP. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT. ALL HARDWARE CURRENTLY REMAINS IMPLANTED. ALTHOUGH THERE HAS BEEN NO INJURY REPORTED AND THIS MALFUNCTION HAS NOT RESULTED IN A REVISION SURGERY TO DATE, THERE HAVE BEEN SIMILAR EVENTS WHERE THIS MALFUNCTION HAS RESULTED IN A REVISION SURGERY. THEREFORE, A MDR WILL BE FILED TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22111814 ↗
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- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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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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