MONARCH 277040700Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034196879), received between Aug 13, 2018 and Feb 16, 2023 — classified as 4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE DEVICES WERE BROKEN. THERE WAS NO PATIENT CONSEQUENCE. NO BROKEN FRAGMENTS WERE RETAINED IN THE PATIENT. THIS REPORT INVOLVES ONE MONARCH SPINE SYSTEM CAP INSERTER. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16384836 ↗
• MalfunctionFeb 6, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING A SPINE PROCEDURE TYPHOON TIP SNAPPED OFF WHILE REMOVING SCREW. SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) CAP INSERTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16305503 ↗
• MalfunctionNov 15, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE CAP INSERTER WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT A THIRD PARTY SERVICER. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CAP INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12814911 ↗
• MalfunctionAug 13, 2018Break; Break

  REMOVAL OF THE MONARCH SYSTEM WAS REPORTED: DR (B)(6), (B)(6) HOSPITAL (B)(6) 2018. PRIMARY IMPLANT DATE 2011. REVISION: REMOVING IMPLANTS FOR SCOLIOSIS CORRECTION. BOTH INSTRUMENTS BROKE AT THE DISTAL TIPS ON TRYING TO REMOVE THE TYPHOON SET CAP - THIS WAS DUE TO BONE FORMATION AROUND THE SCREW HEAD. NO ADVERSE AFFECT TO THE PATIENT AND NO TIME WASTED AS WE COULD USE OTHER ONES ON THE SET AND REMOVED THE BONE PRIOR TO THE THIRD AND FORTH ATTEMPT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7776709 ↗