TRIALTIS 5161-00-0040Recalls & reported problems
Medos International Sàrl · TRIALTIS Spine System Tap,Long 4.0mm 3-5cm ± 1% · Class 1
All models of TRIALTIS (46)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034591827), received between Jan 27, 2026 and Jan 27, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Cut2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2026Failure to Cut
IT WAS REPORTED THAT TIPS BLUNT. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24187378 ↗MalfunctionJan 27, 2026Failure to Cut
IT WAS REPORTED THAT TIPS BLUNT. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24187377 ↗
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
- A.L.P.S.® 8241-50-170Biomet Orthopedics, LLC · TAP, BONE1 recall0 reports
- N/A 876-474Medtronic Sofamor Danek, Inc. · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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