Monarch™ System 1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887761019867), received between Aug 11, 2023 and Oct 10, 2023 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED INCREASED PAIN SINCE SHE STARTED USING THE MONARCH DEVICE ((B)(6) 2023). THE PATIENT STOPPED USING THE DEVICE AND PERFORMED A MRI AS ADVISED BY HER HEALTH CARE PROVIDER. THE RESULTS OF THE MRI SHOWED A FRACTURE OF T7 (SEVENTH THORACIC VERTEBRA). THE PATIENT RECEIVED SURGERY ON (B)(6) 2023 AND IS CURRENTLY RECOVERING FROM IT. THERE WAS NO REPORT OF DEVICE MALFUNCTION. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: Vertebral Fracture

  MAUDE report 17905579 ↗
• InjuryAug 11, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A MASS ON THE RIGHT SIDE OF HIS STERNUM AFTER THE FIRST WEEK OF USING THE MONARCH DEVICE. THE PATIENT WAS TAKEN TO THE URGENT CARE DEPARTMENT WHERE THE X-RAY TESTS PERFORMED SHOWED NO BONE DAMAGE. THE PATIENT WAS DIAGNOSED WITH CHEST WALL ASYMMETRY AND THE URGENT CARE DOCTOR NOTED THE LUMP WAS DUE TO A SHIFT THE OF THE PATIENT'S CARTILAGE. THE PATIENT DID NOT COMPLAIN OF ANY PAIN AND HIS VITAL SIGNS WERE WITHIN NORMAL RANGES. THERE WAS NO REPORT OF DEVICE MALFUNCTION. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17508317 ↗