MIDAS REX MR8 MR8-AVA10 (UDI 00763000441265)Recalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 00763000441265), received between Jun 18, 2024 and Sep 28, 2026 — classified as 1 injury, 99 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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 25 most recent of 100 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Unintended System Motion

  It was reported that, during a surgical procedure, decompression was performed under general anesthesia at L2/3 on the right, with c ontralateral over-the-top decompression on the left, as well as left-sided decompression at L4/5. During the L2/3 decompression, the drill unexpectedly became blocked and subsequently malfunctioned. At the same time, the patient made a sudden and forceful movement of the lower limb despite general anesthesia. Microscopic inspection revealed a focal dural opening adjacent to the right L3 nerve root with low-volume CSF leakage. An intraoperative nerve root injury was suspected. The decompression was carefully continued, andthe right L3 nerve root and contralateral spinal canal were adequately decompressed. The dural opening was treated locally with TachoSil. Hemostasis was achieved, and a Valsalva maneuver at the end of the repair showed no persistent CSF leakage. Additional information was received from the surgeon clarified that the instrument remained securely held, but the burr attachment suddenly thrust forward while operating at full speed. The event occurred within milliseconds without warning, and the exact mechanism could not beconfirmed retros

  Patient problems: Cerebrospinal Fluid Leakage; Dural Tear; Hydrocephalus; Hypovolemia

  MAUDE report 50916319 ↗
• MalfunctionSep 23, 2026No Apparent Adverse Event

  It was reported that the customer had general dissatisfaction over the product. There was no patient impact. Additional information received as bearing detached found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864364 ↗
• MalfunctionSep 16, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787971 ↗
• MalfunctionSep 16, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50784393 ↗
• MalfunctionSep 15, 2026Detachment of Device or Device Component

  It was reported that pre-op, ring is missing. At the time of report there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50768385 ↗
• MalfunctionSep 11, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740787 ↗
• MalfunctionSep 11, 2026Overheating of Device; Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740525 ↗
• MalfunctionSep 11, 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. Additional information was received stating that  detached bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50732690 ↗
• MalfunctionSep 11, 2026No Apparent Adverse Event

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50729768 ↗
• MalfunctionSep 10, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request with no alleged product deficiency. At the time of the report, there was no known impact to the patient. Additional information was received stating that the it was loaner check up, there was no impact to patient and detached distal bearing was found during evaluation made it reportable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713747 ↗
• MalfunctionSep 1, 2026Difficult to Insert

  It was reported that during intra-operative use of a drill, the drill could not be clicked into place and was described as difficult to insert. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50537073 ↗
• MalfunctionAug 28, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50490803 ↗
• MalfunctionAug 27, 2026No Apparent Adverse Event

  It was reported that the customer had general dissatisfaction over the product. There was no impact to the patient at the time of report. Additional information received as bearing detached found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50466523 ↗
• MalfunctionAug 26, 2026Vibration

  It was reported that the device's drill bit was wobbling. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50460740 ↗
• MalfunctionAug 26, 2026No Apparent Adverse Event

  It was reported that device was not working. At the time of report 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 50443935 ↗
• MalfunctionAug 20, 2026Difficult to Remove; Naturally Worn

  It was reported that the tool was stuck inside and the bearings failed. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50341939 ↗
• MalfunctionAug 17, 2026Loss of Power

  It was reported that prior to use, the attachment was frozen. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50277837 ↗
• MalfunctionJul 6, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST WITH NO ALLEGED PRODUCT DEFICIENCY. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING BEARING THAT WAS DETACHED WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25716148 ↗
• MalfunctionJul 6, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WAS NO ALLEGED ISSUE AT THE TIME OF INTAKE. 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 25714925 ↗
• MalfunctionJul 6, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25714778 ↗
• MalfunctionJul 6, 2026Difficult to Insert; Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT OVERHEAT AND DOES NOT HOLD THE TOOL. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25714716 ↗
• MalfunctionJul 6, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT WAS DEFECTIVE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25714079 ↗
• MalfunctionJul 5, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WERE NO ALLEGED ISSUE WITH THE DEVICE. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25712199 ↗
• MalfunctionJul 4, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT BEARINGS WERE BAD. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25709588 ↗
• MalfunctionJul 4, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST WITH NO ALLEGED PRODUCT DEFICIENCY. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING BEARING THAT WAS DETACHED WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25709460 ↗