MONARCH 277020030Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034196435), received between May 15, 2019 and May 5, 2025 — classified as 6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE DRIVER STRIPPED WHILE ATTEMPTING TO REMOVE OLD HARDWARE AND THE TIP OF THE SCREWDRIVER IS NOW LODGED INSIDE THE SCREW HEAD. FRAGMENT GENERATED, FRAGMENT LODGED IN SCREW HEAD. THERE WAS NO SURGICAL DELAY. THE PROCEDURE COMPLETED SUCCESSFULLY. PATIENT CONSEQUENCES WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960805 ↗
• MalfunctionMar 2, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, THE ROUTINE INSPECTION SHOWED UNACCEPTABLE WEAR ON DRIVE TIP. THERE WAS NO PATIENT OUTCOMES REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) HEXLOBE DRIVER, POLY SCREW X15. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16473438 ↗
• MalfunctionMar 2, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, THE ROUTINE INSPECTION SHOWED UNACCEPTABLE WEAR ON DRIVE TIP. THERE WAS NO PATIENT OUTCOMES REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) HEXLOBE DRIVER, POLY SCREW X15. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16473289 ↗
• MalfunctionApr 29, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE WHILE ATTEMPTING TO REMOVE A SCREW, THE TIP OF THE HEXLOBE DRIVER BROKE. THE PLATE WAS REMOVED SUCCESSFULLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) HEXLOBE DRIVER, POLY SCREW X15. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11747202 ↗
• 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 6.25 X 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: Foreign Body In Patient; Not Applicable

  MAUDE report 8684040 ↗
• MalfunctionMay 15, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS OPERATED ON TODAY (B)(6) 2019 BY SURGEON AT THE (B)(6). THIS CASE WAS BOOKED WITH PRISM SURGICAL AND WHEN THE PRISM REPRESENTATIVE WAS THERE THEY DISCOVERED THAT IT WAS A REVISION OF A PREVIOUS CONSTRUCT WHICH HAD USED MONARCH PEDICLE SCREWS. THE PRISM REPRESENTATIVE CALLED TO INFORM ME THAT TWO OF THE MONARCH SCREW DRIVERS 2770-20-303 WERE DAMAGED DURING THE REMOVAL OF THE PEDICLE SCREWS, ONE BROKE AND ONE DRIVER STRIPPED. NO FURTHER INFORMATION WAS GIVEN APART FROM THAT ALL IMPLANTS WERE SUCCESSFULLY REMOVED. THE PRISM REPRESENTATIVE IS UNSURE IF THE DRIVERS ARE AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8611995 ↗