Divergence® Anterior Cervical Fusion System G6626745Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169337534), received between Feb 19, 2017 and Nov 28, 2025 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2025Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE CAGE HAS A SMALL SPLIT IN THE PEEK. PROCEDURE PERFORMED WAS ANTERIOR CERVICAL DISCECTOMY AND FUSION. IT WAS UNKNOWN IF THE CAGE WAS DELIVERED DEFECTIVE OR IT WAS DAMAGED DURING USAGE. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669395 ↗
• MalfunctionMay 22, 2024Mechanical Problem; Defective Device; Mechanical Problem; Defective Device

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, DISTRIBUTOR) REGARDING AN IMPLANT USED FOR SPINAL THERA PY. IT WAS REPORTED THAT THE PRODUCT WAS FOUND MALFUNCTIONING IN PREOP.  THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19368860 ↗
• MalfunctionMar 14, 2023Crack; Crack

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING CERVICAL DISSE CTOMY. IT WAS REPORTED THAT DURING INSTALLATION, WHEN THE NEUROSURGEON WAS SCREWING THE CAGE, HE FELT A GAME. HE THEN DECIDED TO REMOVE THE CAGE, WHICH WAS CRACKED. THE NEUROSURGEON DECIDED TO USE ANOTHER CAGE OF A LARGER SIZE. THE REST OF THE PROCEDURE WENT SMOOTHLY. THERE WAS A SLIGHT EXTENSION OF THE OPERATING TIME AND PROLONGED ANESTHESIA. NO CLINICAL CONSEQUENCE WAS REPORTED TO THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16535364 ↗
• MalfunctionApr 6, 2021Fracture; Fracture

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CERVICAL FORAMINAL STENOSIS FOR SPINAL THERAPY. IT WAS REPORTED THAT INTRA-OPERATIVELY, PRODUCT WAS TAMPED INTO FINAL POSITION WITH A BONE PUNCH AND THE IMPLANT FRACTURED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11620485 ↗
• MalfunctionMar 9, 2020Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNKNOWN SURGERY DUE TO CERVICAL FORAMINAL STENOSIS. INTRA-OP, IMPLANTS WERE TAMPED (FRACTURED) INTO FINAL POSITION WITH A BONE PUNCH. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9804095 ↗
• MalfunctionFeb 23, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL SURGERY DUE TO SOME UNSPECIFIED REASONS. INTRA-OP, CAGE BROKE WHILE IMPLANTING. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7291656 ↗
• MalfunctionNov 16, 2017Break; Break

  PRE-OP DIAGNOSIS: C6/7 MYELOPATH PROCEDURE: C6/7 ANTERIOR CERVICAL DISCECTOMY AND FUSION(ACDF) IT WAS REPORTED THAT DURING SURGERY, THE IMPLANT SPLIT WHEN THE SURGEON IMPACTED THE INSERTER TO PUSH THE IMPLANT INTO PLACE. NO FRAGMENTS WERE REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7037869 ↗
• MalfunctionNov 10, 2017Break; Break

  IT WAS REPORTED THAT PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPINAL STENOSIS AND UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) ON C5-C7. DURING SURGERY, THE LOCKING MECHANISM OF THE IMPLANT BROKE AND GOT SEPARATED FROM THE IMPLANT WHEN THE SURGEON ATTEMPTED TO TURN IT. NO FRAGMENTS WERE LEFT IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7017636 ↗
• MalfunctionFeb 19, 2017Crack; Crack

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT THREE LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION DUE TO PRE-OP DIAGNOSIS AS DEGENERATIVE DISC DISEASE. INTRA-OP, THREE OF THE FOUR CAGES CRACKED WHEN THEY WERE BEING INSERTED. THESE THREE CRACKED CAGES WERE REMOVED. FOURTH CAGE WAS IMPLANTED IN THE PATIENT. THE LOCK MECHANISM OF THE FOURTH CAGE BROKE AND SURGEON HAD TO REMOVE THE SCREWS AND PLATES OVER THE CAGE. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE CRACKED/BROKEN IMPLANTS REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6342638 ↗