MONARCH 277030500Recalls & reported problems
Medos International Sàrl · MONARCH SPINE SYSTEM HEX WRENCH · Class 1
All models of MONARCH (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034196664), received between Sep 5, 2023 and Jun 10, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility2
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION FOR SCOLIOSIS ON MAY 14, 20024. THE SURGEON FOUND A FEW ISSUES WITH THE INSTRUMENTS FROM EXPEDIUM 5.5. THE HEX KEY WRENCH IS SLIGHTLY STRIPPED AND NO LONGER HOLDS THE HEX END OF THE COCR RODS PROPERLY. AS WELL, FOUR OF THE INNER INSERTERS ARE GETTING DAMAGED AT THE DISTAL END TIP, WHERE THE CAP IS LOOSELY HOLDING (WEAR AND TEAR OVER THE YEARS). THE PATIENT WAS NOT IMPACTED, CASE WAS COMPLETED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A DOUBLE END ROD HEX WRENCH. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19505091 ↗MalfunctionSep 5, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM DENMARK REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE WRENCH IN QUESTION WAS FOUND TO NO LONGER GRIP RODS AT THE HEX END. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY USING ANOTHER INSTRUMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MONARCH SPINE SYSTEM HEX WRENCH. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17682497 ↗
Other WRENCH devices
- MONARCH 277040510Medos International Sàrl · WRENCH199 reports
- PINNACLE 2217-50-008Depuy (Ireland) · WRENCH108 reports
- SIGMA 96-1673Depuy (Ireland) · WRENCH102 reports
- P.F.C. 86-5189Depuy (Ireland) · WRENCH92 reports
- Veptr 03.641.004Synthes GmbH · WRENCH86 reports
- RECLAIM 2975-00-300Depuy (Ireland) · WRENCH51 reports
- PINNACLE 2217-50-006Depuy (Ireland) · WRENCH34 reports
- NA 388.261Synthes GmbH · WRENCH32 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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