Midas Rex® EM100-A-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994421999), received between May 10, 2018 and May 15, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Remains Activated” (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. 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.

• InjuryMay 15, 2020Device Remains Activated; Device Remains Activated

  REPAIR REQUEST INITIATED FOR THE MOTOR AND ATTACHMENT WITH NO REPORTED MALFUNCTION. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION STATED THAT A STRYKER PERFORATOR WAS USED TOGETHER WITH THE REPORTED DEVICES. ON FOLLOW-UP, IT WAS CONFIRMED THAT THE PERFORATOR DID NOT STOP DESPITE BREAKING THE CORTEX CAUSING DURA DAMAGE. ALSO, THERE WAS AN EXTENSION TO THE PROCEDURE DUE TO THE SAID EVENT. NO FURTHER INFORMATION CAN BE PROVIDED REGARDING THE EVENT AND THE STATUS OF THE PATIENT.

  Patient problems: Perforation

  MAUDE report 10063279 ↗
• MalfunctionMay 10, 2018Difficult to Insert; Overheating of Device; Difficult to Insert; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF TOOL NOT SEATING PROPERLY. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO OVERHEATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7504125 ↗