Midas Rex Clearview™ SP12MH30Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169308497), received between Jul 18, 2019 and Sep 16, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K081277); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2021Material Separation; Material Separation

  ADDITIONAL INFORMATION RECEIVED MENTIONED THAT THERE WERE NO FRAGMENTS THAT GOT DETACHED OR CAME OFF FROM THE BUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12480866 ↗
• MalfunctionSep 24, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN THE SURGEON WAS USING THE DRILL BIT, IT BROKE. THE PARTS OF THE BROKEN DRILL BIT WERE ALL COLLECTED. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THE INTENDED PROCEDURES WERE LUMBAR 4-LUMBAR 5 AND LUBAR 5 SCAL ONE HEMILAMINECTOMIES, MEDIAL FACETECTOMIES, FORAMINOTOMIES, POSTERIOR INSTRUMENTED FUSION, POSSIBLE INTERBODY FUSION, ALLOGRAFT, AUTO GRAFT, POSSIBLE BONE MORPHOGENIC PROTEIN. UPON FOLLOW UP IT WAS CONFIRMED THAT ANOTHER DRILL BIT WAS USED IN THE SURGERY, THERE WAS NO SIGNIFICANT DELAY, THE SURGEON WAS USING FLUOROSCOPE, THAT AID THE DOCTOR IN GETTING ALL OF THE FRAGMENTS, USING FORCEPS (TWEEZERS). TO CONFIRM, THE SURGICAL TECH IN THE OR, COMPARED THE PIECES OF THE BROKEN DRILL BIT THEY HAD TO THE WHOLE DRILL BIT USED TO COMPLETE THE SURGERY, AND BELIEVED THEY RETRIEVED ALL OF THE PIECES/ FRAGMENTS. THE DEVICE WAS IN THE CONTAINER AND LOOKED 2 GOOD SIZE PIECES BROKE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10579836 ↗
• MalfunctionFeb 17, 2020Material Separation; Material Separation

  A HEALTHCARE PROVIDER REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE BUR HAD BROKEN OFF/SHEARED OFF INTO THE PATIENT. THE SURGEON WAS USING THE BUR WITH IRRIGATION, DISSECTING BONE ON THE VERTEBRAL. WHEN THE DRILL WAS REMOVED, THE TIP OF THE BUR WAS SITTING ON THE VERTEBRAL BODY. THIS WAS REMOVED WITH A FORCEP AND A NEW BUR WAS OPENED. THERE WERE NO BROKEN PIECES THAT REMAINED INSIDE THE PATIENT'S BODY. THE BUR HAD NOT BEEN USED FOR AN EXTENSIVE AMOUNT OF TIME, IT WAS BEING USED WITH IRRIGATION AND ALSO WASN'T HAVING EXCESSIVE FORCE APPLIED TO IT. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9716572 ↗
• InjuryJul 18, 2019Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT A DEVICE TIP BROKE OFF IN PATIENT BACK. X-RAY WAS TAKEN AND ALL PIECES WERE RETRIEVED.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8803138 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081277. One submission often covers many models, so check the product and lot details in each record.

• Z-0961-2022 · Dec 15, 2021 · Terminated
  Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EH