MIDAS REX MR8 MR8-T12BA20DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000514044), received between Apr 8, 2025 and Nov 14, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THE PRODUCT WAS DAMAGED DURING THE USE OF THE DEFECTIVE ITEM IN QUESTION. A WARRANTY CLAIM FOR THE PRODUCT HAS BEEN REQUESTED. THERE WAS NO PATIENT INVOLVED WITH THIS EVENT. THE SPARE PRODUCT WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE, POSTERIOR SPINAL DECOMPRESSION, HAD A DELAY OF APPROX. 5 TO 10 MINUTES AND THERE WAS NO FRAGMENTS LEFT INSIDE THE PATIENT, TIP OF THE BAR WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556397 ↗
• MalfunctionApr 8, 2025Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A CERVICAL LAMINOPLASTY, THE DRILL BIT BROKE OFF IN THE TELESCOPING HANDPIECE MR8-T12AMIS AT THE LOWER PART THAT 'S INSIDE THE TELESCOPING TUBE. IT WAS REPORTED THAT THE PATIENT WAS ALIVE - NO INJURY. IT WAS ALSO NOTED THAT PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S) AND PROCEDURE WAS EXTENDED TIME OF 2 MINUTES TO REOPEN A NEW DRILL TOOL MR8-T12BA20D. ON FOLLOW UP IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21794127 ↗