MONARCH 277050110Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034196923), received between May 28, 2020 and Jun 26, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PART ARRIVED AT OUR WAREHOUSE DAMAGED . THIS REPORT IS FOR ONE (1) DISTRACTOR, 5.50MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199237 ↗
• MalfunctionMay 12, 2023Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON AN UNKNOWN DATE INSERTER WAS LOOSE. IT WAS UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DISTRACTOR, 5.50MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16923654 ↗
• MalfunctionMay 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT WAS UNDERWENT AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2020. AFTER POSTOPERATIVE CLEANSING OF THE DISTRACTOR, IT WAS DISCOVERED THAT THE SPRING HAD COME OFF. IT WAS NOT USED DURING THE PROCEDURE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10097395 ↗