TRIALTIS 5560-12-6050FRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034589657), received between Dec 30, 2024 and Jan 2, 2025 — classified as 8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 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 21053905 ↗
• 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 21042038 ↗
• 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 21041608 ↗
• 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 21036810 ↗
• 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 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 21036535 ↗
• 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 21036517 ↗
• 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 21036001 ↗
• 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 21035870 ↗