Divergence® Anterior Cervical Fusion System G6626747Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169337411), received between Sep 15, 2017 and Jul 18, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DIVERGENCE IMPLANT WAS FOUND TO BE BROKEN UPON UNPACKING PRIOR TO USE. THE IMPLANT WAS NEVER IMPLANTED, AND ANOTHER DIVERGENCE IMPLANT WAS USED INSTEAD. THERE WAS NO PATIENT INVOLVED. THE TYPE OF PROCEDURE INVOLVED DURING THE EVENT WAS ANTERIOR CERVICAL DISC FUSION (ACDF).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545933 ↗
• MalfunctionJan 2, 2020Crack; Crack

  IT WAS REPORTED THAT INTRA-OP, THE IMPLANT CRACKED NEAR SCREW HOLES DURING INSERTION. THE CRACKED IMPLANT WAS THEN COMPLETELY EXPLANTED; AND WAS REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9538630 ↗
• MalfunctionJan 10, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH CERVICAL MYELOPATHY AND UNDERWENT ANTERIOR CERVICAL DISECTOMY AND FUSION AT C3-C4. DURING THE SURGERY, THE IMPLANT BROKE UPON INSERTION. THERE IS NO FRAGMENT OF THE IMPLANT REMAINING IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO TREATMENT OR ADDITIONAL SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8233833 ↗
• MalfunctionSep 15, 2017Break; Break

  IT WAS REPORTED THAT INTRA-OP, THE LATERAL EDGES OF THE IMPLANT BROKE WHEN THE IMPLANTS WERE TAMPED FOR INSERTION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6867803 ↗