Divergence® Anterior Cervical Fusion System G6620526Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169337848), received between Jul 21, 2017 and Jun 14, 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER, DISTRIBUTOR VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, CAGE WAS BROKEN DURING IMPLANTATION. PROCEDURE/TECHNIQUE PERFORMED WAS CERVICAL FUSION. NEW CAGE WAS I MPLANTED AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19535684 ↗
• MalfunctionJul 21, 2017Break; Break

  IT WAS REPORTED THAT INTRA-OP, THE CAGE GOT DAMAGED DURING INSERTION INTO THE C6-7 DISC SPACE. THE DEVICE WAS LEFT INSIDE THE PATIENT AND THE SURGERY WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6731134 ↗