TRIALTIS 5161-00-5116Recalls & reported problems
Medos International Sàrl · TRIALTIS Spine System Retaining Sleeve,Long · Class 2
All models of TRIALTIS (46)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034591797), received between Dec 24, 2025 and Jan 27, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation2
- Device-Device Incompatibility1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2026Material Deformation
IT WAS REPORTED THAT DRIVER SLEEVES BENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24192746 ↗MalfunctionJan 27, 2026Material Deformation
IT WAS REPORTED THAT DRIVER SLEEVES BENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24192735 ↗MalfunctionDec 24, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
THE SCRUB NURSE HAD DIFFICULTY LOADING PEDICLE SCREWS ONTO THE TRIAL IS SCREWDRIVER AND RETAINING SLEEVE. THE MALE THREADS ON THE RETAINING SLEEVE APPEAR TO BE SLIGHTLY DAMAGED. THERE WAS NO PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23888337 ↗
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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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