ACDF Stand Alone Cervical 03.18.305Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040725934), received between Jun 13, 2025 and Jun 13, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 18, 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.

• MalfunctionJun 13, 2025Material Fragmentation; Material Fragmentation

  AFTER PLACEMENT OF THE CAGE, THE SURGEON PREPARED THE SCREW HOLES USING AWL AND TAP. DURING SCREW INSERTION, PART OF THE THREAD (BURRS) WAS SEEN COMING OUT OF THE PLATE. THE SURGEON DECIDED TO REMOVE THE IMPLANT AND REPLACE IT WITH CAGE MECTA-C. OPERATING LEVEL C4-C6, NO ANATOMICAL ABNORMALITIES NOTED. APPROXIMATELY 30 MINUTES DELAY DURING A TOTAL SURGERY TIME OF A COUPLE OF HOURS IN ORDER TO REMOVE THE IMPLANT AND RETRIEVE THE OTHER CAGE WITH ITS DEDICATED INSTRUMENTATION. SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22201145 ↗