NA 03.820.115Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034731568), received between May 2, 2019 and May 2, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2019Break; Break

  IT WAS REPORTED THAT DURING CERVICAL TOTAL DISC REPLACEMENT PROCEDURE ON (B)(6) 2019, THE MILLING DRILL GUIDE BROKE OFF. WHEN THE SURGEON ATTEMPTED TO CUT THE SUPERIOR KEEL, THE DRILL GUIDE BROKE AT THE PROXIMAL PART OF THE TUBE, WHERE THE MILLING BIT IS INSERTED. ALTHOUGH IT WAS NOT IMMEDIATELY CLEAR HOW THE MALFUNCTION OCCURRED, THE BEARINGS WERE OBVIOUSLY DAMAGED. THE SURGEON REMOVED THE ENTIRE DRILL GUIDE WITH THE MILLING BIT STILL IN THE TUBE TO PREVENT ANY METAL BITS FROM GETTING INTO THE PATIENT. ONCE ON THE BACK TABLE, THE DAMAGED INSTRUMENT AND FRAGMENTS WERE PUT INTO A PLASTIC BAG. THE SURGEON CHECKED VISUALLY ON X-RAY TO CONFIRM THAT NO DEBRIS WAS LEFT BEHIND IN THE PATIENT'S BODY. THERE WAS NO SURGICAL DELAY, AND THE SURGEON COMPLETED THE KEEL CUT USING 6MM CHISELS. THERE WAS NO HARM TO THE PATIENT. CONCOMITANT DEVICES: MILLING BIT (PART: 03.820.153S, LOT: H497433, QUANTITY: 1). THIS REPORT IS FOR A MILLING GUIDE 6MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8573585 ↗