MONARCH 277010140Recalls & reported problems
Depuy Spine, LLC · MONARCH SPINE SYSTEM SOUNDING PROBE, STRAIGHT · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034196251), received between Jun 8, 2021 and Mar 4, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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.
Reports received per month
Most reported problems
Device problems
- Break3
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE THE PEDICLE FEELER BROKE INTO TWO PIECES WHILST PROBING A PEDICLE TRACT. BOTH BROKEN PIECES WERE RETRIEVED AND PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21518596 ↗MalfunctionApr 27, 2022Break; Break
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED BY THE SALES REP CUSTOMER IN UNITED KINGDOM THAT THE BALL TIP FEELER DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) SOUNDING PROBE - STRAIGHT DEVICE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14221256 ↗MalfunctionJun 8, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE IMPLANTS APPEARED TO BE DAMAGED. THERE WAS A SURGICAL DELAY OF AN UNKNOWN AMOUNT OF TIME. ANOTHER IMPLANT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS. THIS REPORT INVOLVES ONE (1) MONARCH SPINE SYSTEM SOUNDING PROBE, STRAIGHT. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11957569 ↗
Other PROBE devices
- EXPEDIUM 279702030Depuy Spine, LLC · PROBE53 reports
- Sklar Instruments 94-5923Sklar Corporation · PROBE1 recall0 reports
- Sklar 96-2361Sklar Corporation · PROBE1 recall0 reports
- MOSS 275010140Depuy Spine, LLC · PROBE28 reports
- EXPEDIUM 279702040Depuy Spine, LLC · PROBE21 reports
- MULTILOC 03.019.029Synthes GmbH · PROBE15 reports
- MOSS 275010160Depuy Spine, LLC · PROBE11 reports
- EXPEDIUM 279702010Depuy Spine, LLC · PROBE9 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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