MONARCH 277040525Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034196794), received between Jul 25, 2022 and Jun 1, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON WENT TO USE THE DEVICE FOR FINAL TIGHTENING AND IT KEPT SLIPPING. IT WAS BURRED. ANOTHER FINAL TIGHTENING SHAFT WAS USED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) MODULAR X25 HEXLOBE TORQ DRIVR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039117 ↗
• MalfunctionJul 25, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE SURGEON WAS ATTEMPTING TO FINAL TIGHTEN BUT THE INSTRUMENT WAS BURRED, AND THE STEP COULD NOT BE COMPLETED. THE DRIVER WAS CHANGED AND FINAL TIGHTENING COULD BE PERFORMED. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MONARCH SPINE SYSTEM MODULAR HEXLOBE DRIVER X25. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093124 ↗