TRIALTIS 5161-00-5089Recalls & reported problems
Medos International Sàrl · TRIALTIS Spine System Screwdriver,T27 Navigated · Class 2
All models of TRIALTIS (46)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034589275), received between Aug 14, 2025 and Aug 14, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (6 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 Twisted/Bent6
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS TWISTED, 5/6/7 TAPS BENT, COMPRESSOR AND DISTRACTOR MISSING LOCKING PARTS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22811279 ↗MalfunctionAug 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS TWISTED, 5/6/7 TAPS BENT, COMPRESSOR AND DISTRACTOR MISSING LOCKING PARTS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22811269 ↗MalfunctionAug 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS TWISTED, 5/6/7 TAPS BENT, COMPRESSOR AND DISTRACTOR MISSING LOCKING PARTS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22811238 ↗MalfunctionAug 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS TWISTED, 5/6/7 TAPS BENT, COMPRESSOR AND DISTRACTOR MISSING LOCKING PARTS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22811224 ↗MalfunctionAug 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS TWISTED, 5/6/7 TAPS BENT, COMPRESSOR AND DISTRACTOR MISSING LOCKING PARTS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22811195 ↗MalfunctionAug 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS TWISTED, 5/6/7 TAPS BENT, COMPRESSOR AND DISTRACTOR MISSING LOCKING PARTS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22809914 ↗
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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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