MONARCH 277030000Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705034196565), received between Oct 28, 2019 and Apr 30, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 15 most recent of 15 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 20, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED DURING REPROCESSING, A CRACK WAS DETECTED IN THE INSTRUMENT. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A ROD BENDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13835515 ↗
• MalfunctionJan 19, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE ROD BENDER BROKE DURING USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER BENDER. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THIS REPORT IS FOR ONE (1) 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 13290973 ↗
• MalfunctionAug 6, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE DEVICE BAR WAS BENT AND THE PARTS SEPARATED IMMEDIATELY AFTER CEASING TO ACTUATE THE PART. THE DRIVING PARTS WERE AT DIFFERENT DISTANCES AND IT BROKE INTO FRAGMENTS. THE FRAGMENTS WERE REMOVED. NO PATIENT CONSEQUENCE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) MONARCH SPINE SYSTEM ROD BENDER (FRENCH) . THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10373536 ↗
• MalfunctionJun 17, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2020, THE SURGEON USED THE 5.5 FRENCH ROD BENDER TO BEND A 5.5 TI (TITANIUM) ROD AND THE BENDER BROKE IN HALF. THEY REMOVED THE BROKEN ROD BENDER FROM THE STERILE FIELD AND RETRIEVED A SECOND BENDER TO CONTINUE THE CASE. THE FIRST ROD BENDER WAS NOTED TO BE WORN FROM USE OR AGE. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICES: 5.5 TI ROD (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A FRENCH ROD BENDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10162241 ↗
• MalfunctionDec 19, 2019Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 DURING A POSTERIOR SPINAL FUSION TREATING A THORACOLUMBAR BURST FRACTURE A SCREW BROKE INSIDE THE UNIT WHILE THE SURGEON WAS BENDING A ROD WITH THE ROD BENDER (277030000) AS THE KNOB WAS TURNED TO THE DIRECTION OF ¿SMALL.¿ THERE WERE FRAGMENTS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT WITHOUT SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE FRENCH ROD BENDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9496501 ↗
• MalfunctionOct 28, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE FRENCH ROD BENDER WAS BROKEN. THE PRODUCT HAS BEEN QUARANTINED AND IS AVAILABLE AND IS BEING RETURNED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9244306 ↗