TRIALTIS 5161-00-0060Recalls & reported problems
Medos International Sàrl · TRIALTIS Spine System Tap,Long 6.0mm 3-7cm ± 1% · Class 1
All models of TRIALTIS (46)
Data updated Oct 18, 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 10705034591865), received between Aug 14, 2025 and Jul 27, 2026 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (14 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 Deformation14
- Failure to Cut2
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.
MalfunctionJul 27, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50005106 ↗MalfunctionJul 27, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50005104 ↗MalfunctionJul 27, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50005103 ↗MalfunctionJul 27, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50005101 ↗MalfunctionJul 27, 2026Material Deformation
Tap bent.No patient or user harm reported.No significant delay.Product has been discarded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50005100 ↗MalfunctionJul 27, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50005093 ↗MalfunctionApr 23, 2026Material Deformation
IT WAS REPORTED THAT TAPS WERE BENT WHILE BEING USED IN THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT DELAY ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24973634 ↗MalfunctionApr 23, 2026Material Deformation
IT WAS REPORTED THAT TAPS WERE BENT WHILE BEING USED IN THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT DELAY ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24973626 ↗MalfunctionApr 23, 2026Material Deformation
IT WAS REPORTED THAT TAPS WERE BENT WHILE BEING USED IN THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT DELAY ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24972822 ↗MalfunctionApr 23, 2026Material Deformation
IT WAS REPORTED THAT TAPS WERE BENT WHILE BEING USED IN THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT DELAY ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24972818 ↗MalfunctionJan 27, 2026Failure to Cut
IT WAS REPORTED THAT TIPS BLUNT. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24187373 ↗MalfunctionJan 27, 2026Failure to Cut
IT WAS REPORTED THAT TIPS BLUNT. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24187372 ↗MalfunctionAug 14, 2025Material Deformation; Material Deformation
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 22808756 ↗MalfunctionAug 14, 2025Material Deformation; Material Deformation
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 22808679 ↗MalfunctionAug 14, 2025Material Deformation; Material Deformation
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 22808678 ↗MalfunctionAug 14, 2025Material Deformation; Material Deformation
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 22808378 ↗
Other TAP, BONE devices
- NA 311.43Synthes GmbH · TAP, BONE176 reports
- NA 311.01Synthes GmbH · TAP, BONE106 reports
- NA 311.431Synthes GmbH · TAP, BONE70 reports
- NA 03.424.124Synthes GmbH · TAP, BONE1 recall7 reports
- NA 03.424.126Synthes GmbH · TAP, BONE1 recall0 reports
- N/A 876-474Medtronic Sofamor Danek, Inc. · TAP, BONE1 recall0 reports
- A.L.P.S.® 8241-50-170Biomet Orthopedics, LLC · TAP, BONE1 recall0 reports
- NA 311.44Synthes GmbH · TAP, BONE41 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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