Midas Rex Clearview™ SP14MH30Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169308428), received between Aug 25, 2017 and Feb 28, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 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.

• MalfunctionFeb 28, 2020Break; Break

  UPON FOLLOW UP IT WAS CONFIRMED THAT THERE WAS NO REPORTED FRAGMENTS DETACHED FROM THE DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9768626 ↗
• MalfunctionDec 28, 2018Break; Break

  A REGULATORY BODY REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE HEAD OF THE DEVICE WAS BROKEN WHEN THE BOX WAS OPENED PRIOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8203621 ↗
• MalfunctionSep 6, 2018Break; Break

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BUR TIP WAS PULLED OUT FROM THE OUTER ATTACHMENT AT THE CDOR SPINE DURING A POSTERIOR SPINAL FUSION PROCEDURE. THE DEVICE WAS USED FOR ABOUT A MINUTE. THE WAS A DELAY IN THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7852655 ↗
• MalfunctionAug 25, 2017Break; Break

  THE PHYSICIAN REPORTED THAT THE BUR TIP BROKE OFF DURING THE PROCEDURE. THE SURGEON WAS NOT DRILLING AT THE TIME OF THE EVENT, THE SURGEON WAS PRYING THE BUR LIKE A CURETTE IN THE PATIENT. THERE WERE NO FRAGMENTS IN THE PATIENT. ANOTHER BUR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6821691 ↗

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 E