Divergence® Anterior Cervical Fusion System G6620525Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169337909), received between Aug 29, 2019 and Aug 22, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2025Fracture; Fracture

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING THE SURGICAL PLACEMENT OF THE IMPLANT BY THE PHYSICIAN A FRACTURE OCCURRED ON THE UPPER ANTERIOR SURFACE OF THE IMPLANT. THE DAMAGE WAS IDENTIFIED DURING THE PROCEDURE AND APPEARED TO RESULT FROM MECHANICAL STRESS APPLIED DURING THE POSITIONING OR FIXATION PROGRESS THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE PERFORMED WAS AN ANTERIOR CERVICAL SPINAL FUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22870255 ↗
• MalfunctionMay 24, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) <(>&<)> DISTRIBUTOR VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IM PLANTED WITH STAND-ALONE INTERBODY CAGE HAVING C5, C6, C7 CERVICAL FUSION THERAPY FOR HERNIATED DISC. IT WAS REPORTED THAT THE IMPLANT WAS BROKEN WHEN THE DOCTOR INSERTS THE SCREW INTO THE IMPLANT TO FIX IT. THE DAMAGED IMPLANT WAS REPLACED BY THE DOCTOR AND A NEW IMPLANT WAS IMPLANTED. THERE WAS A DELAY OF 30 MINUTES IN THE OVERALL PROCEDURE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19389603 ↗
• MalfunctionMay 31, 2021Crack; Crack

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL DEVICES USED FOR UNKNOWN SPINAL THERAPY. IT WAS REPORTED WHEN WE PUT THE SCREW IN THERE WAS A CRACK IN THE IMPLANT WHICH LIKELY WAS CREATED FROM IMPACTING THE IMPLANT. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO SYMPTOMS WERE REPORTED.(B)(6) 2021 E1 (REP): ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT ONE IMPLANT BROKE, AND 2 CRACKED. THE CRACKED BETWEEN THE SCREW HOLE AND EDGE OF THE IMPLANT. THERE WAS NO BROKEN FRAGMENT WAS LEFT INSIDE THE PATIENT. NO REVISION WAS PLANNED AND THE SURGERY WAS COMPLETED WITH NEW IMPLANT. THIS WAS A REVISION OF A PREVIOUSLY FUSED C4-7 POSTERIORLY. THE SURGEON DID A C4-7ACDF ON THIS PATIENT AND IT WAS ON THE ANTERIOR THAT THE IMPLANTS BROKE. LEVELS IMPLANTED WAS C4/5, C5/6, C6/7. THE PRODUCT WAS CAME INTO CONTACT WITH THE PATIENT. B)(6) 2021 E2 (REP): ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT PRODUCT NUMBER: G6620525 LOT NUMBER: H5677212 - BROKEN, PRODUCT NUMBER: G6620525 LOT NUMBER: H5677212 - CRACKED AND PRODUCT NUMBER: G6620525 LOT NUMBER: H5461021 - CRACKED. THE REPORTED THREE PROD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11907241 ↗
• MalfunctionAug 29, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CERVICAL ARTHRODESIS. INTRA-OP, THE CAGE BROKE DURING IMPLANTATION. THE BROKEN CAGE WAS COMPLETELY EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8947455 ↗