TRIALTIS 5560-12-6045FRecalls & reported problems
Medos International Sàrl · TRIALTIS Spine System Polyaxial Screw Fenestrated ø6mm x 45mm 5.5 and 6.0 · Class 2 · Implant
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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034594415), received between Apr 24, 2025 and Jan 6, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Compatibility Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Compatibility Problem1
- Device Slipped1
- Migration1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 6, 2026Device Slipped; Migration
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY PATIENT CONSEQUENCES OR NOT ? - YES, AS MENTIONED A REVISION SURGERY WAS NEEDED TO INSERT NEW TRIALTIS INNIES.
Patient problems: Insufficient Information
MAUDE report 23978097 ↗InjuryApr 24, 2025Compatibility Problem; Compatibility Problem
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 21899256 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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