TRIALTIS 5161-00-5034Recalls & reported problems
Medos International Sàrl · TRIALTIS Spine System Sequential Reducer 5.5-6.0,Short Outer 5.5 and 6.0 · Class 1
All models of TRIALTIS (46)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034592190), received between Jun 28, 2024 and Jun 25, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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
- Device-Device Incompatibility5
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE REDUCERS ARE NOT FULLY CLIPPING. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25621889 ↗MalfunctionJun 25, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE REDUCERS ARE NOT FULLY CLIPPING. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25621874 ↗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 21588887 ↗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 21588343 ↗MalfunctionJun 28, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2024 USING TRIALTIS THERE WAS DIFFICULTY USING THE INSTRUMENTS. DURING THE CASE, HE USED A 3-PIECE REDUCTION INSTRUMENT. AFTER THE ROD WAS SEATED AND THE SET SCREW WAS PLACED, THE OUTER SLEEVE OF THE INSTRUMENT WOULD NOT RELEASE FROM THE TOP OF THE SCREW. HE PULLED THE CENTER PORTION OF THE INSTRUMENT OUT COMPLETELY, BUT IT STILL WOULD NOT DISENGAGE. HE FIDDLED WITH THE CLIP AND USED ANOTHER INSTRUMENT TO TRY AND REACH AROUND TO THE BACK OF THE CLIP TO ASSIST IN RELEASING IT. HE WAS EVENTUALLY ABLE TO GET IT TO RELEASE, BUT IT TOOK ABOUT 3-1/2 MINUTES TO GET THE CLIP OFF OF THE TULIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 3.5 MINS AND PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE TRIALTIS SPINE SYSTEM SEQUENTIAL REDUCER 5.5-6.0,SHORT OUTER 5.5 AND 6.0 THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19634833 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 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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