Midas Rex 9TA30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169766037), received between Feb 26, 2021 and Sep 20, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (2 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING CRANIOTOMY THE "THICK SKULL" CRANIOTOME MECHANISM BROKE IN THE PATIENT'S SKULL AND TORN DURA MATER, LENGTHENING OF THE OPERATING TIME REQUIRED TO REPAIR THE DURA MATTER. IT WAS ALSO REPORTED THAT THE BROKEN PIECE(S) RETRIEVED.

  Patient problems: Spinal Cord Injury

  MAUDE report 17779939 ↗
• InjuryFeb 26, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE BURR WAS BROKEN AND THE TIP OF THE BURR WAS LEFT INSIDE THE PATIENT'S LEFT KNEE. IT WAS CONFIRMED BY A POST-SURGERY X-RAY AND IT WAS CONSIDERED SAFE TO BE LEFT IN THE BONE. ON FOLLOW-UP, IT WAS REPORTED THAT THERE WILL BE NO REVISION SURGERY TO REMOVE THE BROKEN PIECE AND THE REMAINING PART OF THE TOOL WAS DISCARDED BY THE CUSTOMER. IT WAS ALSO REPORTED THAT NO FURTHER INFORMATION CAN BE PROVIDED REGARDING THE EVENT AND THE STATUS OF THE PATIENT POST-SURGERY.

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

  MAUDE report 11388328 ↗

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)