MIDAS REX MR8 MR8-14BA20DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000490232), received between Sep 10, 2024 and May 8, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE FOR SPONDYLOLISTHESIS, THE NEUROSURGEON WAS USING A DRILL TO CREATE PEDICLE HOLES WHEN ONE DRILL BIT FRACTURED, FOLLOWED BY FRACTURE OF THE SECOND DRILL BIT. THE PROXIMAL FRAGMENTS OF BOTH DRILL BITS WERE RETRIEVED FROM THE PATIENT. IT WAS REPORTED THERE WAS A DELAY IN TREATMENT OF 20 MINS. IT WAS REPORTED THAT THE PATIENT WAS ALIVE - NO INJURY. ADDITIONAL INFORMATION RECEIVED STATING THAT, BURR FRACTURED IN A CLEAN AND WELL-DEFINED MANNER, AND ALL BROKEN PARTS WERE IMMEDIATELY IDENTIFIED AND RETRIEVED DURING THE PROCEDURE. AN INTRAOPERATIVE O-ARM SCAN WAS PERFORMED AT THE END OF THE INTERVENTION AS A FINAL CHECK BEFORE CLOSING THE PATIENT. NO ADDITIONAL PROCEDURES WERE REQUIRED TO RETRIEVE BROKEN PARTS, AS ALL FRAGMENTS WERE RECOVERED PROMPTLY, AND THE FINAL IMAGING CONFIRMED COMPLETE REMOVAL. THE PATIENT IS DOING WELL AND DID NOT EXPERIENCE ANY CONSEQUENCES AS A RESULT OF THE BURR BREAKAGE. ALL FRAGMENTS OF THE BROKEN BURRS WERE IMMEDIATELY IDENTIFIED AND REMOVED DURING THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque; Unintended Radiation Exposure

  MAUDE report 25126870 ↗
• InjuryFeb 18, 2026Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE FOR SPONDYLOLISTHESIS, THE NEUROSURGEON WAS USING A DRILL TO CREATE PEDICLE HOLES WHEN ONE DRILL BIT FRACTURED, FOLLOWED BY FRACTURE OF THE SECOND DRILL BIT. THE PROXIMAL FRAGMENTS OF BOTH DRILL BITS WERE RETRIEVED FROM THE PATIENT. IT WAS REPORTED THERE WAS A DELAY IN TREATMENT OF 20 MINS. IT WAS REPORTED THAT THE PATIENT WAS ALIVE - NO INJURY. ADDITIONAL INFORMATION RECEIVED STATING THAT, BURR FRACTURED IN A CLEAN AND WELL-DEFINED MANNER, AND ALL BROKEN PARTS WERE IMMEDIATELY IDENTIFIED AND RETRIEVED DURING THE PROCEDURE. AN INTRAOPERATIVE O-ARM SCAN WAS PERFORMED AT THE END OF THE INTERVENTION AS A FINAL CHECK BEFORE CLOSING THE PATIENT. NO ADDITIONAL PROCEDURES WERE REQUIRED TO RETRIEVE BROKEN PARTS, AS ALL FRAGMENTS WERE RECOVERED PROMPTLY, AND THE FINAL IMAGING CONFIRMED COMPLETE REMOVAL.

  Patient problems: Device Embedded In Tissue or Plaque; Unintended Radiation Exposure

  MAUDE report 24375097 ↗
• InjuryFeb 18, 2026Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE FOR SPONDYLOLISTHESIS, THE NEUROSURGEON WAS USING A DRILL TO CREATE PEDICLE HOLES WHEN ONE DRILL BIT FRACTURED, FOLLOWED BY FRACTURE OF THE SECOND DRILL BIT. THE PROXIMAL FRAGMENTS OF BOTH DRILL BITS WERE RETRIEVED FROM THE PATIENT. IT WAS REPORTED THERE WAS A DELAY IN TREATMENT OF 20 MINS. IT WAS REPORTED THAT THE PATIENT WAS ALIVE - NO INJURY. ADDITIONAL INFORMATION RECEIVED STATING THAT, BURR FRACTURED IN A CLEAN AND WELL-DEFINED MANNER, AND ALL BROKEN PARTS WERE IMMEDIATELY IDENTIFIED AND RETRIEVED DURING THE PROCEDURE. AN INTRAOPERATIVE O-ARM SCAN WAS PERFORMED AT THE END OF THE INTERVENTION AS A FINAL CHECK BEFORE CLOSING THE PATIENT. NO ADDITIONAL PROCEDURES WERE REQUIRED TO RETRIEVE BROKEN PARTS, AS ALL FRAGMENTS WERE RECOVERED PROMPTLY, AND THE FINAL IMAGING CONFIRMED COMPLETE REMOVAL.

  Patient problems: Device Embedded In Tissue or Plaque; Unintended Radiation Exposure

  MAUDE report 24375089 ↗
• MalfunctionSep 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE LISTHESIS SURGERY, THE NEUROSURGEON WAS MAKING THE HOLE FOR SCREW INSERTION WHEN THE FINAL PART OF THE BURR (2 MM BALL) BROKEN IN THE PATIENT'S PEDICLE. THERE WAS INTERVENTION PERFORMED DURING THAT NEUROSURGEON HAS REMOVED THE FINAL PART OF THE BROKEN BURR (THE 2 MM BALL) FROM THE PEDICLE OF THE PATIENT. IT WAS REPORTED THAT THE PATIENT WAS ALIVE WITH NO INJURY AND THE PROCEDURE WAS EXTENDED FOR 20 MINUTES. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20256467 ↗
• InjurySep 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE OF AN EXPANSIVE INTRACANAL EXTRADURAL DORSOL D2-D6 LESION THE TOOL BROKEN AND THE BALL WHICH BLEW OFF THE STEM REMAINED IN THE PATIENT'S BODY. ON (B)(6) 2024 THE FRAGMENT OF BROKEN TOOL WAS INTERCEPTED BY MRI CONTROL DURING THE POST-OP. IT WAS NECESSARY TO PROCEED WITH A RE-INTERVENTION OF THE PATIENT TO REMOVE THE FRAGMENTS FROM PATIENT BODY ON (B)(6) 2024. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT, BROKEN PIECES RETRIEVED FROM PATIENT'S BODY AND THE TOOL WAS DISCARDED. IT WAS ALSO REPORTED THAT THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 20180812 ↗