MIDAS REX MR8 MR8-AF02 (UDI 00763000441005)Recalls & reported problems

Summary

The FDA's MAUDE database contains 952 adverse event reports that list this exact device (DI 00763000441005), received between May 16, 2023 and Sep 30, 2026 — classified as 2 injuries, 950 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (288 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 952 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Overheating of Device; Vibration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951953 ↗
• MalfunctionSep 30, 2026No Apparent Adverse Event

  It was reported that the attachment is faulty. At the time of event, there is no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950664 ↗
• MalfunctionSep 30, 2026No Apparent Adverse Event

  It was reported that there was no issue. No additional information was received. There were analysis findings.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946573 ↗
• MalfunctionSep 30, 2026Difficult to Remove

  It was reported that the tool was stuck inside the attachment. There was no patient impact. Additional information was received upon evaluation stating that the distal bearings were detached.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944452 ↗
• MalfunctionSep 30, 2026Loss of Power

  It was reported that the device was faulty. There was no impact to the patient at the time of report. Additional information received as distal bearings detached found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943100 ↗
• MalfunctionSep 29, 2026Naturally Worn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934413 ↗
• MalfunctionSep 29, 2026No Apparent Adverse Event

  It was reported that the customer had general dissatisfaction over the product. There was no patient involvement or impact. Additional information received as bearings misaligned found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930216 ↗
• MalfunctionSep 29, 2026Naturally Worn

  It was reported that prior to use, there was bearing damage. No patient involvement and impact was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930065 ↗
• MalfunctionSep 28, 2026Corroded

  It was reported that rust was observed in the device. At the time of report there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911958 ↗
• MalfunctionSep 28, 2026No Apparent Adverse Event

  It was reported that prior to use device was defective. At the time of report there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911716 ↗
• MalfunctionSep 28, 2026Difficult to Insert; Loss of Power

  It was reported that the device was seized and the craniotome does not fit tightly. There was no patient impact in the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911501 ↗
• MalfunctionSep 28, 2026No Apparent Adverse Event

  It was reported that the device is faulty. It was reported that there was no patient impact. Additional information received stating detached bearing was found during evaluation made it reportable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911451 ↗
• MalfunctionSep 28, 2026No Apparent Adverse Event

  It was reported that during procedure the inner part of the attachment is loose, which compromises the normal operation of the tool. There was no patient involved with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911019 ↗
• MalfunctionSep 28, 2026Naturally Worn

  It was reported that after use, the bearings in the attachment were damaged. There was no patient involved in this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910939 ↗
• MalfunctionSep 25, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request and no alleged product deficiencies were reported. It was reported that there was no patient impact. Additional information was received stating that loose bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895722 ↗
• MalfunctionSep 25, 2026Naturally Worn

  It was reported that the device bearing was damaged prior to use. It was reported that there was no patient involvement. Additional information was received stating that detached bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895332 ↗
• MalfunctionSep 25, 2026Naturally Worn

  It was reported that during pre-op the bearings were broken . At the time of report no patient was involved . Additional information received that bearings were detached during evaluation. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894553 ↗
• MalfunctionSep 24, 2026Naturally Worn

  It was reported that the bearings were damaged. There was no patient involvement. Additional information received upon evaluation stating that the bearings were detached.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883953 ↗
• MalfunctionSep 24, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request, and no alleged product deficiencies were reported. There was no patient impact in this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883084 ↗
• MalfunctionSep 24, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request, and no alleged product deficiencies were reported. At the time of report there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882906 ↗
• MalfunctionSep 24, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request and no alleged product deficiencies were reported. It was reported that there was no patient impact. Additional information was received stating that misaligned bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877990 ↗
• MalfunctionSep 24, 2026Detachment of Device or Device Component

  It was reported that ball bearing fell out off the attachment. It was reported that there was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877716 ↗
• MalfunctionSep 23, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873399 ↗
• MalfunctionSep 23, 2026Difficult to Remove

  It was reported that the drill bit used to create the bone flap is stuck and cannot be removed. It was reported that there was no patient impact. Additional information was received stating that detached bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866476 ↗
• MalfunctionSep 23, 2026Naturally Worn

  It was reported that prior to use, the bearing was broken. It was reported that there was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865204 ↗