TRIALTIS 5161-00-5065Recalls & reported problems
Medos International Sàrl · TRIALTIS Spine System Hex Handle · Class 1
All models of TRIALTIS (46)
Data updated Oct 16, 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 10705034598239), received between Mar 12, 2025 and Mar 12, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED WHEN USING THE TURNDOWN REDUCER, IT DID NOT CATCH THE TULIP THREADS AND JUST SPINS.
Patient problems: Insufficient Information
MAUDE report 21588891 ↗MalfunctionMar 12, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED WHEN USING THE TURNDOWN REDUCER, IT DID NOT CATCH THE TULIP THREADS AND JUST SPINS.
Patient problems: Insufficient Information
MAUDE report 21588348 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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