TRIALTIS 5560-55-3095TRecalls & reported problems
Medos International Sàrl · TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Bevel Ends ø5.5mm x 95mm 5.5 · Class 2 · Implant
All models of TRIALTIS (46)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034603742), received between Apr 24, 2025 and Apr 24, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Device Slipped” (1 report).
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
- Device Slipped1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 24, 2025Device Slipped; Device Slipped
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ROD FROM A TRIALTIS SCREW SLIPPED OUT. THE SET SCREW STAYED IN THE SCREW; HOWEVER, THE ROD CAME OUT. THE SURGEON ADMITTED THAT IT WAS LIKELY USER ERROR BUT WANTED TO HAVE THE SCREW AND CAP CHECKED OUT. PATIENT UNDERWENT HARDWARE/EXPLANT REMOVAL ON (B)(6) 2025 TO FIX THE ROD AND SET SCREWS. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. IMPLANT DATE: (B)(6) 2025. EXPLANT DATE: (B)(6) 2025.
Patient problems: Insufficient Information
MAUDE report 21899131 ↗
Other Thoracolumbosacral pedicle screw system devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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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