TRIALTIS 5560-12-4535FSRecalls & reported problems
Medos International Sàrl · TRIALTIS Spine System Polyaxial Screw Fenestrated ø4.5mm x 35mm 5.5 and 6.0 · Class 2 · Implant
All models of TRIALTIS (46)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034585277), received between Dec 30, 2024 and Jan 2, 2025 — classified as 4 injuries.
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
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- Unspecified Infection4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION ON (B)(6) 2024. OVER THE FOLLOWING WEEKEND, THE PATIENT PRESENTED WITH AN INFECTION. PATIENT HAD BEEN IMPLANTED WITH TRIALTIS THORACOLUMBAR SYSTEM. IN ADDITION TO IMPLANTING TRIALTIS, THE SURGEON USED CONFIDENCE BONE CEMENT.
Patient problems: Unspecified Infection
MAUDE report 21053887 ↗InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT HAD BEEN IMPLANTED WITH THE TRIALTIS THORACOLOUMBAR SYSTEM AND DEVELOPED AN INFECTION. THE SURGEON STATED HE IS NEW TO USING TRIALTIS AND HE TYPICALLY DOES NOT SEE INFECTIONS; HE IS CONCERNED THE INFECTIONS MAY BE RELATED TO THE IMPLANTS AND INSTRUMENTATION. IN ADDITION TO IMPLANTING TRIALTIS, CONFIDENCE BONE CEMENT WAS USED.
Patient problems: Unspecified Infection
MAUDE report 21036848 ↗InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION ON (B)(6) 2024. OVER THE FOLLOWING WEEKEND, THE PATIENT PRESENTED WITH AN INFECTION. PATIENT HAD BEEN IMPLANTED WITH TRIALTIS THORACOLUMBAR SYSTEM. IN ADDITION TO IMPLANTING TRIALTIS, THE SURGEON USED CONFIDENCE BONE CEMENT.
Patient problems: Unspecified Infection
MAUDE report 21035978 ↗InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT HAD BEEN IMPLANTED WITH THE TRIALTIS THORACOLUMBAR SYSTEM AND DEVELOPED AN INFECTION. THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2024. THE SURGEON INCIDENT HE IS NEW TO USING TRIALTIS AND STATES HE TYPICALLY DOES NOT SEE INFECTIONS; HE IS CONCERNED THE INFECTIONS MAY BE RELATED TO THE IMPLANTS AND INSTRUMENTATION. IN ADDITION TO IMPLANTING TRIALTIS, CONFIDENCE BONE CEMENT WAS USED.
Patient problems: Unspecified Infection
MAUDE report 21035727 ↗
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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