MONARCH 177492060Recalls & reported problems
Medos International Sàrl · MONARCH SPINE SYSTEM END TO END DUAL CONNECTOR 5.5mm - 5.5mm · Class 2 · Implant
All models of MONARCH (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034063058), received between Dec 9, 2021 and Jan 5, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Slipped” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Slipped1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Joint Laxity1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. . THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: NON-UNION, SPINAL IMBALANCE COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS REPORT INVOLVES ONE MONARCH SPINE SYSTEM END TO END DUAL CONNECTOR 5.5MM - 5.5MM THIS IS REPORT 1 OF 6 FOR (B)(4).
Patient problems: Joint Laxity; Nonunion/Delayed-union Bone Fracture
MAUDE report 18452710 ↗InjuryDec 9, 2021Device Slipped; Device Slipped
IT WAS REPORTED THAT ON (B)(6) 2021,THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE CONNECTOR THAT CAME LOOSE FROM ROD. CUSTOMER WOULD LIKE TO HAVE CONNECTOR EVALUATED. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS REPORT IS FOR (1) MONARCH SPINE SYSTEM END TO END DUAL CONNECTOR 5.5MM - 5.5MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12969718 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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