Midas Rex™ 10BA30DCRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169757561), received between Jan 2, 2018 and Aug 1, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 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.

• InjuryAug 1, 2018Material Separation; Dull, Blunt; Appropriate Device Problem Term/Code Not Available; Material Separation; Dull, Blunt

  IT WAS REPORTED THAT THE DOCTOR NOTICED THAT THE DIAMETER OF THE TOOL TIP BALL OF 10BA30DC BECOME SMALLER FOR ABOUT 1 MM AFTER CUTTING THE LUMBAR FOR ABOUT 20 TO 30 MINS .IT WAS ALSO REPORTED THAT THE DIAMOND AND METAL FROM THE TOOL WHICH WERE CONSIDERED TO HAVE ENTERED INTO THE PATIENT'S BODY WERE ASPIRATED TO THE EXTENT THAT THEY COULD BE ASPIRATED WITH BOTH SALINE AND BONE FRAGMENTS. IT WAS ALSO STATED THAT ALTHOUGH IT WAS IMPOSSIBLE TO REMOVE ALL THE THINGS WHICH HAD ENTERED INTO THE PATIENT'S BODY, NO ABNORMALITIES WAS OBSERVED WHEN THE PATIENT WAS BEING MONITORED AFTER THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 7741147 ↗
• InjuryJan 2, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT THE (B)(6) MIDAS DIAMOND TOOL BUR DIAMOND COATING PEELED OFF, AND IT WAS DROPPED IN PATIENT BODY. SURGEON TRIED TO REMOVE BUT HE WAS NOT ABLE TO REMOVE ALL OF FRAGMENTS. SO, A PART OF DIAMOND COATING IS REMAINING IN PATIENT BODY. IT WAS REPORTED THAT THERE WAS A 10 MINUTE DELAY IN THE SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED USING BACK UP PRODUCTS. IT WAS ALSO REPORTED THE PATIENT WAS ¿ALIVE: NO INJURY¿. IT WAS NOTED THAT A FEW BROKEN PIECES REMAINED IN THE PATIENT¿S FACIA AND SUBCUTIS UNDER X-RAY IMAGES. THE PHYSICIAN DETERMINED THAT THE SITE WHERE THE BROKEN PIECE REMAINED IN THE BODY WAS NOT A PLACE TO GIVE A HEALTH HAZARD TO THE PATIENT, THE PHYSICIAN WOULD NOT RE-OPEN THE INCISION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7158191 ↗

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)