MIDS REX MR8 MR8-10BA40DRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000487218), received between Dec 13, 2023 and Apr 14, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CUTTER FRACTURED AT THE JUNCTION BETWEEN THE SHANK AND THE BALL. THIS RAISED A SIGNIFICANT RISK OF BREACH AND POTENTIAL LOSS OF THE BUR TIP INTO THE SPINAL CANAL. HOWEVER, ADDITIONAL INFORMATION INDICATED THAT THE FRAGMENT WAS RETRIEVED WITH PLIERS WITHIN FIVE MINUTES, AND THERE WAS NO IMPACT ON THE PATIENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE ADDITIONAL DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24869736 ↗
• MalfunctionAug 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SPINAL RECALIBRATION TOOL BROKE. IT WAS REPORTED THAT THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN END FROM THE PATIENT'S BONE AND THERE WAS A DELAY OF TEN MINUTES IN PROCEDURE AS  A RESULT OF THE EVENT. THE PROCEDURE WAS COMPLETED WITH THE BACKUP PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22725154 ↗
• MalfunctionMar 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT TIP OF DRILL BROKEN DURING THE USE AND THE PROCEDURE WAS COMPLETED WITH THE BACKUP PRODUCT. IT WAS REPORTED THAT THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AND THERE WAS DELAY IN PROCEDURE FOR TWO MINUTES. NO ADDITIONAL INTERVENTION WAS PERFORMED OR PLANNED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21735836 ↗
• MalfunctionMar 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING LUMBAR COLUMN SURGERY, DRILL BROKE. IT WAS ALSO REPORTED THAT THERE WAS A 05 MINUTE PROCEDURE DELAY AND NO INTERVENTION DUE TO THE EVENT. THE SURGERY WAS COMPLETED USING A BACKUP DEVICE. ON FOLLOW UP IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721029 ↗
• MalfunctionApr 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PATIENT UNDERGOING TREATMENT FOR C4-C7 LAMINECTOMY, AT THE BEGINNING OF THE PROCEDURE THE BALL OF THE DIAMENTED CUTTER DETACHED FROM THE STEM AND THE SURGEON REPORTED IT IMMEDIATELY, THE BALL WAS VISIBLE AND WAS REMOVED FROM THE SURGICAL SITE USING FORCEPS. ADDITIONAL INFORMATION REGARDING THE EVENT IS BEING FOLLOWED UP FROM THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133849 ↗
• MalfunctionMar 8, 2024Fracture; No Apparent Adverse Event; Noise, Audible; Fracture; No Apparent Adverse Event; Noise, Audible

  IT WAS REPORTED THAT DURING SPINE SURGERY MR8-10BA40D TOOL BROKE INTO TWO PIECES AFTER A SHRILL NOISE APPEARED. IT WAS REPORTED THAT THE BROKEN TOOL FELL INTO THE PATIENT'S BODY BUT WAS RECOVERED AND THE PROCEDURE WAS COMPLETED WITH A BACKUP PRODUCT.IT WAS ALSO REPORTED THAT THERE WAS NO INTERVENTION AND PROCEDURE EXTENDED TO 15 MINUTES. ON FOLLOWUP- IT WAS CONFIRMED THAT THERE WAS NO PATIENT OR STAFF IMPACT DUE TO THE EVENT AND THE PATIENT IS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18864626 ↗
• MalfunctionJan 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT WHEN MILLING THE INTERBODY SPACE, THE MILLING CUTTER BROKE OFF IN THE PATIENT NEAR THE DURA MATER AND CUTTER CHANGE ENDANGERING THE PATIENT. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18442068 ↗
• MalfunctionDec 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE TOOL WAS BROKEN AND THE PROCEDURE WAS COMPLETED USING BACKUP PRODUCT. IT WAS ALSO REPORTED THAT THERE WAS NO PROCEDURE DELAY AND THE PATIENT IS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT WAS BEING FOLLOWED UP FROM THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18323686 ↗