MIDS REX MR8 MR8-10BA20DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000487072), received between Oct 22, 2025 and Jan 21, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Fracture

  IT WAS REPORTED THAT DURING ENDOSCOPIC TRANSSPHENOIDAL RESECTION OF A PITUITARY TUMOR, THE BURR HEAD FRACTURED, RENDERING THE DEVICE UNUSABLE. IT WAS ALSO REPORTED THAT THERE IS A 5 MINUTES OF SURGICAL DELAY AND THE PROCEDURE COMPLETED WITH BACKUP PRODUCTS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127623 ↗
• MalfunctionNov 18, 2025Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A POSTERIOR CERVICAL SPINE DECOMPRESSION AND FIXATION PROCEDURE, A MATCHHEAD TOOL FRACTURED WHILE CREATING A PILOT HOLE FOR A CERVICAL PEDICLE SCREW USING THE MOTOR. THE PATIENT¿S BONE WAS REPORTED TO BE SCLEROTIC, AND INCREASED FORCE WAS APPLIED AS THE SHAFT WAS THICKER THAN THE TIP BALL DIAMETER (2 MM). THE PROCEDURE WAS COMPLETED USING A SPARE PRODUCT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23578604 ↗
• MalfunctionOct 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A SPINAL SURGERY, THE TOOL FRACTURED WHILE IN USE. THE PROCEDURE WAS COMPLETED USING A BACKUP PRODUCT WITHOUT ANY REPORTED DELAY. THERE WAS NO REPORTED PATIENT INJURY OR IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356342 ↗