MIDAS REX MR8 MR8-14MH30TRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000490768), received between Mar 21, 2023 and Aug 12, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2025Fracture; Difficult to Remove; Fracture; Difficult to Remove

  IT WAS REPORTED THAT THE TOOL WAS STUCK IN PATIENT. ADDITIONAL INFORMATION WAS BEING FOLLOWED UP.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22780343 ↗
• MalfunctionApr 18, 2025Overheating of Device; Smoking; Dull, Blunt; Overheating of Device; Smoking; Dull, Blunt

  IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A 3 LEVEL POSTERIOR LUMBAR INTERBODY FUSION (PLIF) SURGERY, PLACING 8 SCREWS. WHILE PLACING THE 5TH SCREW THEY COMPLAINED THAT THE BIT WAS DULL AND THEY WANTED A NEW ONE. IT WAS NOTICED THERE WAS A LOT OF SMOKE COMING OUT OF THE INCISION SITE. WHEN THE DRILL WAS PASSED BACK, IT WAS NOTICED THE BIT HAD TURNED BLACK AND BLUE AND IT HAD BLUE RESIDUE ON IT FROM BURNING A HOLE THROUGH THE DRAPES. A WET RAYTEC WAS PUT ON IT TO COOL IT DOWN AND IT STARTED TO STEAM AND MAKE POPPING NOISES. THE BIT WAS SWITCHED OUT FOR A NEW ONE TO DRILL THE REMAINING SCREWS AND THE BIT AGAIN TURNING BLUE AND BLACK AND WAS DULL. THE MR8 DRILL MOTOR WAS WARM AS WELL. NO PATIENT IMPACT WAS REPORTED. IT WAS ALSO NOTED THAT THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. ON FOLLOW UP, IT WAS CONFIRMED WITH THE HEALTH CARE PROFESSIONAL THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864503 ↗
• MalfunctionApr 18, 2025Overheating of Device; Smoking; Dull, Blunt; Overheating of Device; Smoking; Dull, Blunt

  IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A 3 LEVEL POSTERIOR LUMBAR INTERBODY FUSION (PLIF) SURGERY, PLACING 8 SCREWS. WHILE PLACING THE 5TH SCREW THEY COMPLAINED THAT THE BIT WAS DULL AND THEY WANTED A NEW ONE. IT WAS NOTICED THERE WAS A LOT OF SMOKE COMING OUT OF THE INCISION SITE. WHEN THE DRILL WAS PASSED BACK, IT WAS NOTICED THE BIT HAD TURNED BLACK AND BLUE AND IT HAD BLUE RESIDUE ON IT FROM BURNING A HOLE THROUGH THE DRAPES. A WET RAYTEC WAS PUT ON IT TO COOL IT DOWN AND IT STARTED TO STEAM AND MAKE POPPING NOISES. THE BIT WAS SWITCHED OUT FOR A NEW ONE TO DRILL THE REMAINING SCREWS AND THE BIT AGAIN TURNING BLUE AND BLACK AND WAS DULL. THE MR8 DRILL MOTOR WAS WARM AS WELL. NO PATIENT IMPACT WAS REPORTED. IT WAS ALSO NOTED THAT THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. ON FOLLOW UP, IT WAS CONFIRMED WITH THE HEALTH CARE PROFESSIONAL THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864469 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SPINE SURGERY DECOMPRESSION ,THERE WAS DURAL TEAR. IT WAS REPORTED THAT THE DURAL REPAIR TOOK APPROXIMATELY 45 MINUTES. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. ADDITIONAL INFORMATION REGARDING THE EVENT IS BEEN FOLLOWED UP. ON FOLLOW UP IT WAS CONFIRMED THAT THERE IS NO MALFUNCTION CAUSED BY TOOL.

  Patient problems: Nerve Damage; Spinal Cord Injury

  MAUDE report 16582262 ↗