MIDS REX MR8 MR8-10BA50DXRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000487317), received between Mar 27, 2025 and Sep 28, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 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 50916753 ↗
• MalfunctionFeb 11, 2026Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE BUR WAS BROKEN. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS AND THERE IS NO BROKEN PIECES REMAIN INSIDE THE PATIENT'S BODY. IT WAS ALSO REPORTED THAT THERE WAS NO ANY ADDITIONAL INTERVENTION PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24311045 ↗
• MalfunctionApr 1, 2025Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  IT WAS REPORTED THAT TOOL BROKEN DURING PROCEDURE. IT WAS ALSO REPORTED THAT THERE WAS NO PATEINT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21736092 ↗
• MalfunctionMar 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT INTRA-OP LUMBAR FUSION, TOOL BROKE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. THERE WAS DELAY OF LESS THAN AN HOUR AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734059 ↗
• MalfunctionMar 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT INTRA-OP LUMBAR FUSION, TOOL BROKE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. THERE WAS DELAY OF LESS THAN AN HOUR AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733988 ↗
• MalfunctionMar 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT BUR WAS BROKEN DURING PROCEDURE. NO PATIENT IMPACT REPORTED. ON FOLLOW UP IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT AND THE NAME OF THE PROCEDUR IS L5-S1 FUSION. IT WAS REPORTED THAT THERE WAS NO FRAGMENTS LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718026 ↗
• MalfunctionMar 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT TOOL BROKE DURING THE SACROILIAC AND THORACOLUMBAR. THERE WAS NO DELAY IN PROCEDURE AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED WITH THE BACKUP PRODUCT. ON FOLLOW-UP IT WAS REPORTED THAT THERE IS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707368 ↗
• MalfunctionMar 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE HEAD OF THE TOOL WAS BROKEN. NO PATIENT IMPACT REPORTED. ON FOLLOW UP, IT WAS CONFIRMED WITH THE HEALTH CARE PROFESSIONAL THAT THERE WAS NO PATIENT OR STAFF IMPACT. PROCEDURE IS SPINAL FUSION AND THERE WAS DELAY OF 1-2 MINUTES TO REPLACE TOOL. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21704729 ↗