TRIALTIS 5161-00-5006Recalls & reported problems
Medos International Sàrl · TRIALTIS Spine System Screwdriver,T27 Long Cannulated · Class 1
All models of TRIALTIS (46)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705034592152), received between Aug 5, 2025 and Sep 25, 2026 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (13 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
- Material Twisted/Bent13
- Device-Device Incompatibility2
- Break1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Material Twisted/Bent
It was reported that the driver tip is stripped. There was no patient harm and no surgical delay reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899677 ↗MalfunctionSep 25, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899670 ↗MalfunctionJul 27, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50007876 ↗MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THAT PRODUCT TIP WAS ROUNDED DUE TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23594554 ↗MalfunctionSep 15, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT ON (B)(6) 2025, PRODUCT BECAME DAMAGED OR BENT UPON SCREW INSERTION. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO DELAY IN SURGERY AND SURGERY WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23058299 ↗MalfunctionSep 9, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PRODUCT WAS DAMAGED/STRIPPED UPON TIGHTENING OF SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23009298 ↗MalfunctionSep 9, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PRODUCT WAS DAMAGED/STRIPPED UPON TIGHTENING OF SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23009293 ↗MalfunctionAug 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED. THE 5/6/7 TAPS WERE BENT, AND THE COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22808733 ↗MalfunctionAug 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED. THE 5/6/7 TAPS WERE BENT, AND THE COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22808727 ↗MalfunctionAug 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED. THE 5/6/7 TAPS WERE BENT, AND THE COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22808703 ↗MalfunctionAug 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED. THE 5/6/7 TAPS WERE BENT, AND THE COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22808700 ↗MalfunctionAug 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED. THE 5/6/7 TAPS WERE BENT, AND THE COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22808676 ↗MalfunctionAug 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED. THE 5/6/7 TAPS WERE BENT, AND THE COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22808675 ↗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 22808385 ↗MalfunctionAug 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS TWISTED, THE TAPS WERE BENT, THE COMPRESSOR AND DISTRACTOR WAS MISSING LOCKING PARTS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22806978 ↗MalfunctionAug 5, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED ON (B)(6) 2025, THE DRIVER TIP WAS CHIPPED AND DID NOT ATTACH TO THE SCREW. NO FRAGMENTS WERE GENERATED. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22719424 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 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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