TRIALTIS 5560-01-0000Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705034589664), received between Jun 3, 2024 and Jun 10, 2026 — classified as 17 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Mechanical Problem; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2026, THAT WHEN FINAL TIGHTENING 2 TRIALTIS SET SCREWS COMPLETELY STRIPPED THREADS OUT IN SAME SCREW TULIP HEAD, 3RD SET SCREW/3RD ATTEMPT WORKED. THIS WAS A SAI SCREW 8X65MM, NO COUNTER TORQUE WAS USED BECAUSE THE SCREW WAS BURIED IN BONE AND COUNTER TORQUE COULD NOT FIT OVER TULIP HEAD. 5 MINUTES SURGERY DELAYED DUE TO THE REPORTED EVENT. TRIED AGAIN WITH NEW SET SCREW. PROCEDURE WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE GENERATED AND THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25462107 ↗
• 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 21899276 ↗
• 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 21053893 ↗
• 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 21042045 ↗
• 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 21041660 ↗
• 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 21041629 ↗
• 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 21041589 ↗
• 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 21041567 ↗
• 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 21041526 ↗
• 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 21036805 ↗
• 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 21036545 ↗
• 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 21036536 ↗
• 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 21036527 ↗
• 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 21036495 ↗
• 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 21036463 ↗
• 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 21036461 ↗
• 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 21035986 ↗
• 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 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 21035759 ↗
• MalfunctionSep 10, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. DURING SURGERY A SET SCREW CROSS THREADED. SURGEON WAS USING THE THREAD DOWN REDUCER AND THE SET SCREW INSERTER. SET SCREW WAS REMOVED AND REPLACED. SURGEON CONTINUED ON AS PLANNED. THERE WAS A SHORT DELAY IN SURGERY TO GET A NEW SET SCREW AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A SET SCREW T27.

  Patient problems: Insufficient Information

  MAUDE report 20184526 ↗
• MalfunctionSep 10, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, WHILE DROPPING THE SET SCREW THROUGH THE SEQUENTIAL REDUCER, IT MUST HAVE CROSS THREADED AND THE SET SCREW SHEARED OFF. THERE WAS NO DELAY IN CASE AND NO HARM TO PATIENT. THIS REPORT IS FOR A SET SCREW T27.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20183924 ↗
• MalfunctionAug 27, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20080173 ↗
• MalfunctionJun 3, 2024Break; Break

  IT WAS REPORTED THAT ON MAY 7, 2024, THE SETS SCREWS WERE SHEARED. THIS OCCURED INTRAOPERATIVELY. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. THE PATIENT OUTCOME WAS DOING GREAT WITH NO ISSUES. THIS REPORT INVOLVES ONE (1) SET SCREW T27 THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19455045 ↗
• MalfunctionJun 3, 2024Break; Break

  IT WAS ALSO NOTED THAT THE FRAGMENTS WERE GENERATED BUT REMOVED EASILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454826 ↗