MONARCH 277030110Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034196619), received between Jul 18, 2019 and Dec 3, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SURGEON WAS USING THE KERRISON STYLE ROD HOLDER AND CLAMPED THE ROD TOO HARD, BREAKING THE CLASP IN THE ARM THAT LOCKS THE ROD INTO THE HOLDER. ADDITIONALLY, WHEN FINAL TIGHTENING, THE RESIDENT DID NOT APPLY ENOUGH COUNTER TORQUE CAUSING THE FINAL TIGHTENER TO STRIP TWO OF THEM. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834681 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING POST OP INSPECTION, IT WAS FOUND THAT INSTRUMENTS WERE BROKEN. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821583 ↗
• MalfunctionNov 19, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENT WAS BROKEN DURING SURGERY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724673 ↗
• MalfunctionJun 14, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE ROD HOLDER WAS DAMAGED AND NOT SECURELY HOLDING THE ROD IN PLACE. THE MECHANISM THAT LOCKS THE ROD INTO THE HOLDER WAS DAMAGED AND DOES NOT LOCK THE ROD IN SECURELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY BY USING ANOTHER INSTRUMENT. THERE WAS NO PATIENT IMPACT. THIS REPORT INVOLVES ONE MONARCH SPINE SYSTEM ROD HOLDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19542851 ↗
• MalfunctionDec 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON NOVEMBER 15, 2023, THE DEVICE WAS PASSING THE ROD AND THE HOLDER, AND NO LONGER WORKED PROPERLY. THE DEVICE WOULD NO LONGER LOCK PROPERLY USING THE LOCKING MECHANISM ON THE HANDLE. THERE WAS NO PATIENT CONSEQUENCE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT INVOLVES ONE MONARCH SPINE SYSTEM ROD HOLDER . THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18275587 ↗
• MalfunctionNov 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE SCREW CAME LOOSE FROM THE KERRISON WHILE IN USE BY THE SURGEON. THERE WAS NO DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES . NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) KERRISON ROD HOLDER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049220 ↗
• MalfunctionMar 25, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE KERRISON ROD HOLDER BROKE WHILE REMOVING A ROD. SURGEON HAD APPLIED EXCESSIVE ROTATIONAL FORCE TO THE INSTRUMENT RESULTING IN THE INSTRUMENT TO FAIL. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN , QUANTITY 1). THIS REPORT IS FOR ONE (1) ROD HOLDER, KERRISON STYLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9879363 ↗
• MalfunctionJul 18, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, AFTER ANTERIOR & POSTERIOR LUMBAR FUSION SURGERY, THE KERRISON ROD HOLDER BROKE. IT WAS UNKNOWN HOW THE ISSURE WAS DISCOVERED. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8804249 ↗