MONARCH 277040710Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034196886), received between Oct 3, 2014 and Jun 10, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO THE SURGEON WANTED TO REMOVE SCREWS AS THEY HAD BEEN IN SITU FOR AROUND 15 YEARS. WHILE REMOVING A MONARCH 6.25X 5.5 MM SCREWS, THERE WERE THREE (3) INSTRUMENTS BROKE. A TWO (2) BROKEN TEETH OF THE CAP INSERTER WERE RETRIEVED BUT THE BROKEN POLYAXIAL SCREW TIP IS STILL IN THE PATIENT. THE MONARCH SCREW WAS RELOCKED AND TORQUED OFF, HENCE THE REMAINING TIP OF THE SCREW CANNOT BE DISLODGED. THUS, THE SURGEON IS CONFIDENT THAT THE BROKEN PIECE WILL NOT MIGRATE AT ALL AS IT IS COVERED BY THE SAME LIKE PRODUCT. IT WAS MADE MENTION THAT THE SCREWS WHEREIN THE S1 BONE AND WAS UNATTACHED TO THE ROD. IT WAS NOT REMOVED DUE TO SOLID FUSION FOR 15 YEARS SINCE 2004. ALL THREE ITEMS TAGGED WITH RED REPAIR TAG. FRAGMENTS WERE GENERATED BUT IT WAS EASILY REMOVED. THERE WAS A SURGICAL DELAY OF 60 SECONDS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: Not Applicable

  MAUDE report 8684221 ↗
• MalfunctionJun 10, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO THE SURGEON WANTED TO REMOVE SCREWS AS THEY HAD BEEN IN SITU FOR AROUND 15 YEARS. WHILE REMOVING A MONARCH 6.25X 5.5 MM SCREWS, THERE WERE THREE (3) INSTRUMENTS BROKE. A TWO (2) BROKEN TEETH OF THE CAP INSERTER WERE RETRIEVED BUT THE BROKEN POLYAXIAL SCREW TIP IS STILL IN THE PATIENT. THE MONARCH SCREW WAS RELOCKED AND TORQUED OFF, HENCE THE REMAINING TIP OF THE SCREW CANNOT BE DISLODGED. THUS, THE SURGEON IS CONFIDENT THAT THE BROKEN PIECE WILL NOT MIGRATE AT ALL AS IT IS COVERED BY THE SAME LIKE PRODUCT. IT WAS MADE MENTION THAT THE SCREWS WHEREIN THE S1 BONE AND WAS UNATTACHED TO THE ROD. IT WAS NOT REMOVED DUE TO SOLID FUSION FOR 15 YEARS SINCE 2004. ALL THREE ITEMS TAGGED WITH RED REPAIR TAG. FRAGMENTS WERE GENERATED BUT IT WAS EASILY REMOVED. THERE WAS A SURGICAL DELAY OF 60 SECONDS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: Not Applicable

  MAUDE report 8684000 ↗
• MalfunctionAug 13, 2018Break; Break

  REMOVAL OF THE MONARCH SYSTEM WAS REPORTED: DR (B)(6), (B)(6) HOSPITAL (B)(6) 2018. PRIMARY IMPLANT DATE 2011. REVISION : REMOVING IMPLANTS FOR SCOLIOSIS CORRECTION. BOTH INSTRUMENTS BROKE AT THE DISTAL TIPS ON TRYING TO REMOVE THE TYPHOON SET CAP - THIS WAS DUE TO BONE FORMATION AROUND THE SCREW HEAD. NO ADVERSE AFFECT TO THE PATIENT AND NO TIME WASTED AS WE COULD USE OTHER ONES ON THE SET AND REMOVED THE BONE PRIOR TO THE THIRD AND FORTH ATTEMPT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7776732 ↗
• MalfunctionOct 3, 2014Break

  INTERNATIONAL AFFILIATE REPORTED THAT IT WAS NOTICED BEFORE SURGERY THAT THE MONARCH CAP INSERTER AND THE MONARCH SHORT CAP INSERTER WERE DAMAGED AT THE TIPS. IT WAS LATER REVEALED THAT THE TABS ON THE DISTAL TIPS OF THE CAP INSERTERS WERE CLEANLY BROKEN OFF THE INSTRUMENTS INTRA-OPERATIVELY AND WERE RETRIEVED FROM THE PATIENT. THE NURSE PUT THE BROKEN TABS IN HER SHARPS DISH AND DISCARDED THEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO RESULTING DELAY. THE FOLLOWING MFG. MEDWATCH REPORTS ARE BEING FILED FOR THE MONARCH CAP INSERTER AND MONARCH SHORT CAP INSERTER THAT WERE INVOLVED IN THIS EVENT: 1526439-2014-11956, 1526439-2014-11957.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 4140690 ↗