NA 03.820.153SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034731827), received between Apr 5, 2018 and Apr 5, 2018 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 5, 2018Break; Break

  IT WAS REPORT THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2018 FOR TREATMENT OF A SPINE CERVICAL ARTIFICIAL DISC REPLACEMENT (PDC) IMPLANT AT C5-C6 DISC LEVELS. PATIENT WAS IMPLANTED WITH ONE (1) LEVEL UNKNOWN PDC IMPLANT. INTER-OPERATIVELY, IT WAS REPORTED THAT A MILLING BIT HXC INSTRUMENT TIP BROKE DURING THE PROCEDURE. AFTER THE SURGEON HAD COMPLETED THE SUPERIOR KEEL CUT, THE MILLING BIT WAS PLACED IN THE INFERIOR KEEL PORT. THE BIT TIP BROKE AFTER MILLING WAS ONLY ABOUT 80% COMPLETE. NO HARM WAS REPORTED TO THE PATIENT. THE MILLING BIT WAS REMOVED BY REMOVING THE GUIDE AND THE KEEL CUT WAS COMPLETED USING A CHISEL. THE CASE PROCEEDED WITHOUT ISSUE. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. PATIENT IS REPORTED IN STABLE CONDITION. REPORTER HAS NO MORE INFORMATION TO REPORT ON THIS EVENT. CONCOMITANT DEVICE UNKNOWN ARTIFICIAL DISC REPLACEMENT PDC (ITEM # UNKNOWN, LOT # UNKNOWN, QUANTITY 1 EACH). THIS REPORT IS FOR ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7401680 ↗