MONARCHRecalls & reported problems across all models
Depuy Spine, LLC · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 7 models of MONARCH by Depuy Spine, LLC in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Oct 3, 2014 and Apr 30, 2026 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Break” (24 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MONARCH problems
Device problems
- Break24
- Device-Device Incompatibility3
- Material Deformation2
- Corroded1
- Detachment of Device or Device Component1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Consequences Or Impact To Patient7
- Not Applicable2
MONARCH models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MONARCH 277030000BENDER15 reports
- MONARCH 277040700DRIVER, PROSTHESIS4 reports
- MONARCH 277040710DRIVER, PROSTHESIS4 reports
- MONARCH 277010140PROBE3 reports
- MONARCH 277030135ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- MONARCH 177016245ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- MONARCH 277040415DRIVER, PROSTHESIS1 report
Recent MONARCH adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE FRENCH ROD BENDER COMPLETELY FELL APART DURING SURGERY. THE EVENT INVOLVED THE DEVICE DISASSEMBLING, WITH PIECES HITTING THE USER, THE PATIENT, AND FALLING TO THE FLOOR, LEAVING THE SPRING SPINNING. THE DEVICE WAS IMMEDIATELY REMOVED FROM CIRCULATION AND PLACED IN A CLEAR BAG. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR CLINICAL SYMPTOMS RESULTING FROM THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25046383 ↗MalfunctionOct 24, 2025Break; Break
IT WAS REPORTED THAT THE TOP HINGE POPPED OFF OF THE ROD BENDER AFTER BEING USED FOR BENDING ROD. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23383446 ↗MalfunctionSep 18, 2025Break; Break
IT WAS REPORTED THAT THE ROD BENDER BROKE WHILE BENDING THE ROD. THERE WAS NO DELAY IN SURGERY . THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. FRAGMENTS WERE GENERATED BUT WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23084820 ↗MalfunctionJun 4, 2025Break; Break
IT WAS REPORTED THAT THERE WAS UNEXPECTED BREAKDOWN OF THE ITEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22139961 ↗MalfunctionApr 21, 2025Break; Corroded; Break; Corroded
IT WAS REPORTED THAT ON AN UNKNOWN DATE ONE OF THE KNOBS ON THE FRENCH BENDER (TOP RIGHT) WAS BROKEN OFF WHILE THE SURGEON WAS BENDING THE ROD. ITS AN OLDER PIECE OF EQUIPMENT AND IT JUST SNAPPED OFF AND LOOKED RUSTY. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21871949 ↗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 ↗MalfunctionNov 12, 2024Break; Break
IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024, WHEN THE SURGEON TRIED TO BEND THE LORDOTIC TITANIUM ROD 5.5 LENGTH 75MM WITH A ROD BENDER, IT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20664398 ↗MalfunctionAug 23, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ROD HOLDER WAS UNABLE TO HOLD THE ROD TIGHTLY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) ROD CLAMP, RATCHETING, STRAIGHT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20047185 ↗MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ROD HOLDER WAS UNABLE TO HOLD THE ROD TIGHTLY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) ROD CLAMP, RATCHETING, STRAIGHT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20043600 ↗MalfunctionJun 21, 2024Break; Break
IT WAS REPORTED THAT DURING A POSTERIOR CERVICO-THORACIC FUSION SURGERY ON (B)(6) 2024, THE ROD BENDER IN QUESTION BROKE OFF WHEN THE SURGEON WAS BENDING RODS. THERE WAS NO PROBLEM WITH HIS USAGE. THERE ARE NO BROKEN PARTS LEFT IN THE PATIENT'S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MONARCH SPINE SYSTEM ROD BENDER (FRENCH). THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19587278 ↗MalfunctionApr 22, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT ON (B)(6) 2024, THE LOAN KIT INSTRUMENT WAS BURRED DURING THE CASE. THERE WAS NO DELAY TO THE CASE, AND THERE WAS NO ADVERSE OUTCOMES TO THE PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) MONARCH SPINE SYSTEM HEXLOBE DRIVER X25. THIS IS REPORT 1 OF 1 FOR (B)(4) .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19154388 ↗MalfunctionMay 19, 2023Break; Break
THE DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT WHILE USING THE ROD BENDER FROM THE EXPEDIUM SET, THE MIDDLE KNOB ON THE FRENCH BENDER BROKE APART FROM THE METAL CYLINDER THAT CONNECTS THE TWO HANDLES. THE INSTRUMENT BROKE APART INTO FIVE PARTS. CENTRAL KNOB, CYLINDER, TWO HANDLES, AND WASHER. ALL PARTS WERE RETRIEVED FROM THE STERILE FIELD. THERE WAS NO SURGICAL DELAY DUE TO THE RELATED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE GENERATED BUT WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) FRENCH ROD BENDER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16961199 ↗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 ↗MalfunctionJul 11, 2022Break; Break
IT WAS REPORTED THAT THIS WAS AN ANTERIOR FUSION PERFORMED ON (B)(6) 2022. THE ROD BENDER BROKE OFF DURING ROD BENDING. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE SURGICAL DELAY. IT WAS LATER CONFIRMED THAT A WELDED ARE ON THE DEICE SEEMED TO BE DAMAGED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) FRENCH ROD BENDER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14977252 ↗
Other Depuy Spine, LLC products
All Depuy Spine, LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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