MIDAS REX MR8 MR8-ND13BA45DCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000513764), received between Feb 3, 2025 and Mar 17, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING ORL PROCEDURE THE BALL BECAME DETACHED FROM THE SHEATH. TWO TOOLS, WITH THE SAME BATCH HAD THIS FAULT AND THEY USED A THIRD ONE WITH AN ANOTHER BATCH AND ABLE TO PROCEED THE SURGERY, WITHOUT ANY PROBLEM. THERE WAS NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT AND PROCEDURE DELAY WAS BEING FOLLOWED UP FROM THE FACILITY. ON ADDITIONAL FOLLOW UP THERE WAS A FEW MINUTES OF PROCEDURE DELAY OCCURRED TO GET SOME MORE CLEAR VIEW FROM THE ARSENAL AND THERE WAS NO PATIENT OR STAFF IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621240 ↗
• MalfunctionMar 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING ORL PROCEDURE THE BALL BECAME DETACHED FROM THE SHEATH. TWO TOOLS, WITH THE SAME BATCH HAD THIS FAULT AND THEY USED A THIRD ONE WITH AN ANOTHER BATCH AND ABLE TO PROCEED THE SURGERY, WITHOUT ANY PROBLEM. THERE WAS NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT  AND PROCEDURE DELAY WAS BEING FOLLOWED UP FROM THE FACILITY. ON ADDITIONAL FOLLOW UP THERE WAS A FEW MINUTES OF PROCEDURE DELAY OCCURRED TO GET SOME MORE CLEAR VIEW FROM THE ARSENAL AND THERE WAS NO PATIENT OR STAFF IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621162 ↗
• MalfunctionFeb 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING DECOMPRESSION PROCEDURE DRILL BIT SHEARED OFF. NO PATIENT IMPACT REPORTED. IT WAS ALSO REPORTED THAT NO DAMAGED PIECE REMAINED IN THE PATIENT'S BODY AND 10 MINUTES OF DELAY IN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT WAS BEING FOLLOWED UP FROM THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294796 ↗