MIDAS REX LEGEND 7BA40DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000061609), received between Mar 21, 2023 and Apr 17, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 reports).

9 other recalls cover devices cleared under the same FDA submission (K020069); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT TOOL WAS BROKEN. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858793 ↗
• MalfunctionApr 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT TOOL WAS BROKEN. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858762 ↗
• MalfunctionMar 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT WHEN USING A SURGICAL BUR, IT BROKE IN TWO. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT BUT THE BROKEN PIECE FELL INTO THE OPERATING CAVITY. ON FOLLOW-UP IT WAS REPORTED THAT THE PROCEDURE IS POSTERIOR FOSSA TUMOR AND NO FRAGMENTS LEFT INSIDE THE PATIENT. IT WAS ALSO REPORTED THAT THERE WAS A PROCEDURE DELAY AND NO POST-OPERATIVE ISSUES TO THE PATIENT. ON FURTHER FOLLOW-UP IT WAS REPORTED THAT TOOL IS NOT RECEIVED AT MEDTRONIC END AND IS LOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21709812 ↗
• MalfunctionMar 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TOOL WAS BROKEN. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.  ADDITIONAL INFORMATION REGARDING THE EVENT WAS BEING FOLLOWED-UP. ON FOLLOW UP IT WAS REPORTED THAT CUSTOMER WAS DISCARDED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21705574 ↗
• InjuryMar 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING OPERATION THE DIAMOND DRILL BROKE OFF IN THE NECK OF A PATIENT. IT WAS ALSO REPORTED THAT THERE WERE NO CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION REGARDING THE EVENT WAS BEING FOLLOWED UP FROM THE FACILITY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16581903 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020069. One submission often covers many models, so check the product and lot details in each record.

• Z-1602-2016 · Apr 8, 2016 · Terminated
  Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
• Z-0321-2016 · Oct 21, 2015 · Terminated
  Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
• Z-0546-2010 · Nov 30, 2009 · Terminated
  Medtronic Midas Rex Legend Footed Attachment, AF01. Intended for use with all Legend and Legend EHS motors for general surgery including maxillofacial , craniofacial and sternotom
• Z-2156-2008 · May 30, 2008 · Terminated
  Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23 Medtronic Powered Surgical Solutions, Forth Worth, TX Intended for use in Spinal, Cranial, Orthopedic, General S
• Z-1574-05 · Sep 1, 2005 · Terminated
  Medtronic Midas Rex Classic, GS and Legend dissecting tools manufactured by Medtronic Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, tX 76137 USA, Rx only, S
• Z-1067-05 · Jun 29, 2005 · Terminated
  Medtronic MIDAS REX Legend High Speed Pneumatic System, Gold Touch Motor. Manufactured by Medtronic, Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, TX 76137
• Z-0278-05 · Nov 11, 2004 · Terminated
  Medtronic Midas Rex Legend High Speed Pneumatic System
• Z-0213-05 · Nov 3, 2004 · Terminated
  Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A, manufactured by Medtronic Powered Surgical Solutions, Fort Worth, Texas
• Z-0419-03 · Nov 11, 2002 · Terminated
  Legend Lubricant System (Legend Gold, Gold Touch and Platinum motors and Legend Lubricant/Diffuser cartridge)