N/A 698344848Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034575155), received between May 22, 2024 and May 22, 2024 — 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.

• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THERE WAS C3-5 ACDF WITH CODA IMPLANT SYSTEM. THE DRILL BIT WAS USED WITH A DOUBLE BARREL DTS GUIDE AND RUBS AGAINST THE DRILL BIT, SHEDDING SMALL METAL PIECES. THE PIECES WERE REMOVED WITH A SUCTION AND NO PATIENT EVENT AT THAT TIME. THE DOUBLE BARREL DTS GUIDES ARE BEING REMOVED FROM THE HOSPITAL. THE DESIGN OF THE GUIDES ALLOWS FLEXING WHILE THE DRILL WAS BEING USED, WHICH CAUSED SHEDDING FROM THE DRILL BIT. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) MODIFIED INSTRUMENT DRILL,SHORT 16MM. THIS IS REPORT 4 OF 8 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372519 ↗
• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THERE WAS C3-5 ACDF WITH CODA IMPLANT SYSTEM. THE DRILL BIT WAS USED WITH A DOUBLE BARREL DTS GUIDE AND RUBS AGAINST THE DRILL BIT, SHEDDING SMALL METAL PIECES. THE PIECES WERE REMOVED WITH A SUCTION AND NO PATIENT EVENT AT THAT TIME. THE DOUBLE BARREL DTS GUIDES ARE BEING REMOVED FROM THE HOSPITAL. THE DESIGN OF THE GUIDES ALLOWS FLEXING WHILE THE DRILL WAS BEING USED, WHICH CAUSED SHEDDING FROM THE DRILL BIT. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) MODIFIED INSTRUMENT DRILL,SHORT 16MM. THIS IS REPORT 3 OF 8 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372444 ↗