N/A 6975015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169777934), received between Mar 30, 2018 and Feb 21, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH HERNIATED DISC AND UNDERWENT CERVICAL ARTHROPLASTY WITH INSTRUMENTATION SURGERY AT C4-C5 LEVELS. DURING SURGERY, WHILE DRILLING THROUGH THE DRILL GUIDE, AFTER THE FIRST HOLE WAS MADE, THE DRILL BIT SHEARED AT THE FLUTED END. THE TIP BROKE OFF INSIDE THE GUIDE AND THE PATIENT¿S ENDPLATE. NO FRAGMENT OF THE INSTRUMENT WERE REMAINING IN THE PATIENT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8356950 ↗
• MalfunctionMar 30, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNSPECIFIED SURGERY. INTRA-OP, TIP OF THE DRILL BIT BROKE DURING THE DRILLING STEP. NO PATIENT COMPLICATIONS WERE REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7385245 ↗