Divergence® Anterior Cervical Fusion System G6626525Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00643169337558), received between Apr 19, 2017 and Jan 20, 2026 — classified as 75 malfunctions.

The most frequently reported specific device problem is “Break” (60 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 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C5/6/7. PRE-OP DIAGNOSIS OF PATIENT WAS CERVICAL HERNIA. IT WAS REPORTED THAT, A CRACK DEVELOPED AND THE CAGE BROKE DURING INSERTION WITH THE FREE-HAND INSERTER. 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 24115062 ↗
• MalfunctionOct 30, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING AN EVENT WHICH OCCURRED DURING A C5-C6 ACDF PROCEDURE IN A PATIENT. IT WAS REPORTED THAT WHEN CAGE DIVERGENCE WAS INSERTED INTO THE INSERTER AND KNOCKED WITH HAMMER, IT BROKE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425151 ↗
• MalfunctionJul 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING DISCECTOMY PROC EDURE FOR ACUTE CERVICAL PAIN IT WAS REPORTED THAT THE CAGE BROKE WHILE A SCREW WAS BEING INSERTED. THE CAGE WAS EXPLANTED AND A DIFFERENT CAGE WAS IMPLANTED AT ONE CERVICAL LEVEL. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME AND 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 22607380 ↗
• MalfunctionJul 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE CAGE WAS BROKEN WHEN TRYING TO INSERT SCREWS. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO ALLEGATION OR MALFUNCTION ASSOCIATED WITH SCREW. THE PROCEDURE INVOLVED IN THE EVENT IS ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AND PRE-OP DIAGNOSIS IS CERVICAL PAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479559 ↗
• MalfunctionJun 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE FUSION DEVICE WAS SCREWED IN DURING THE OPERATION, IT BROKE. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326025 ↗
• MalfunctionJun 10, 2025Break; Product Quality Problem; Break; Product Quality Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY USING SELF-STABILIZING CERVICAL FUSION FIXATION SYSTEM. IT WAS REPORTED THAT THE DEVICE WAS FRACTURED WHILE SCREWING. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE ARE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AS THE EVENT OCCURRED DURING IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174503 ↗
• MalfunctionJun 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A C6/7 SPINAL FUSION PROCEDURE IN A PATIENT DIAGNOSED WITH DROPPED HEAD SYNDROME. IT WAS REPORTED THAT AFTER THE PRODUCT WAS INSERTED ON C6/7, DAMAGE WAS CONFIRMED AND THE DEVICE WAS REMOVED; AFTER THE SECOND PRODUCT WAS INSERTED, DAMAGE TO THE CAGE WAS CONFIRMED AND THE DEVICE WAS REMOVED AGAIN. THERE WAS A DELAY OF LESS THAN 60 MINS. THERE ARE NO IMPLANT DEBRIS LEFT IN THE PATIENT'S BODY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22141307 ↗
• MalfunctionJun 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A C6/7 SPINAL FUSION PROCEDURE IN A PATIENT DIAGNOSED WITH DROPPED HEAD SYNDROME. IT WAS REPORTED THAT AFTER THE PRODUCT WAS INSERTED ON C6/7, DAMAGE WAS CONFIRMED AND THE DEVICE WAS REMOVED; AFTER THE SECOND PRODUCT WAS INSERTED, DAMAGE TO THE CAGE WAS CONFIRMED AND THE DEVICE WAS REMOVED AGAIN. THERE WAS A DELAY OF LESS THAN 60 MINS. THERE ARE NO IMPLANT DEBRIS LEFT IN THE PATIENT'S BODY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22141246 ↗
• MalfunctionMay 16, 2025Fracture; Product Quality Problem; Fracture; Product Quality Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A CAGE USED ON PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING THE SURGERY, WHEN THE SURGEON WAS INSERTING THE INTERVERTEBRAL DISC FOR SPINAL FUSION, IMPLANT IMMEDIATELY FRACTURED. THIS ISSUE IS RELATED PRODUCT QUALITY. THERE WAS NO DELAY REPORTED. UPON DISCOVERING THAT THE INTERVERTEBRAL DISC IMPLANT FRACTURED DURING THE PROCEDURE, A REPLACEMENT IMPLANT WAS USED TO ENSURE THE SURGERY COULD PROCEED AS PLANNED. LEVEL IMPLANTED WAS C3-C4. 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 22032757 ↗
• MalfunctionMay 2, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C4-C5 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). IT WAS REPORTED THAT THE CAGE WAS BROKEN DURING THE INSERTION. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949016 ↗
• MalfunctionMar 25, 2025Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGOING FOR CERVICAL SPONDYLOSIS. IT WAS CONFIRMED THAT FRACTURE OF IMPLANTED FUSION DEVICE DURING OPERATION. EXPLANT COMPLETED. NO PATIENT SYMPTOMS OR COMPLICATIONS RELATED TO THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED DUE TO THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT, CERVICAL SPONDYLOSIS WAS THE PRE OP DIAGNOSIS FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21687304 ↗
• MalfunctionMar 13, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN ANTERIOR CERVICAL ARTHROSIS PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THE CAGE BROKE DURING THE PROCEDURE WHEN IT WAS IMPACTED. THEY WERE USING THE HAND LOCK SPECIFICALLY FOR THE CAGE. THERE WAS NO PATIENT SYMPTOM REPORTED BECAUSE AS SOON AS THE CAGE WAS IMPACTED IT WAS OBSERVED THAT IT HAD BROKEN, SO THE CAGE WAS IMMEDIATELY REPLACED WITH ANOTHER ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21591616 ↗
• MalfunctionMar 2, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR CERVICAL HERNIA. IT WAS REPORTED THAT, THE CAGE WAS BROKEN WHEN IT WAS DRIVEN ADDITIONALLY USING THE TRIAL AS AN IMPACTOR. THE PROCEDURE OR TECHNIQUE PERFORMED WAS ANTERIOR CERVICAL DISCECTOMY AND FUSION AND THE LEVELS PLANNED WERE C6/C7. THERE WAS A DELAY OF LESS THAN 60 MINUTES REPORTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FRAGMENT OF BROKEN CAGE LEFT INSIDE THE PATIENT BODY. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21500897 ↗
• MalfunctionFeb 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING FUSION FOR CERVICAL DISC HERNIATION. IT WAS REPORTED THAT THE CAGE FRAGMENTED DURING IMPLANTATION AND WAS TAKEN OUT ON THE SPOT. 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 21456981 ↗
• MalfunctionFeb 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY VIA A USER REPORT REGARDING A PATIENT HAVING C2-C6 DECOMPRESSION AND FUSION POSTERIOR OF THE CERVICAL SPINE. IT WAS REPORTED THAT WHILE BEING TAMPED INTO THE INTERBODY SPACE, THE CAGE CRACKED IN TWO PLACES. THE CAGE WAS CAREFULLY REMOVED AND REPLACED WITH A CAGE OF THE SAME SIZE. 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 21442398 ↗
• MalfunctionFeb 20, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE DOCTOR WAS IMPLANTING THE CAGE WITH THE CORRECT GUIDE, AFTER PLACING THE CAGE AND REMOVING THE GUIDE, THE DOCTOR DECIDED TO ADJUST THE CAGE, HOWEVER, WITHOUT THE GUIDE, IT WAS DIFFICULT AND AFTER REMOVING THE GUIDE, THERE WAS NO WAY TO GET IT BACK. THEREFORE, THE DOCTOR TRIED TO IMPACT THE CAGE WITH AN IMPROVISED INSTRUMENT, CAUSING THE CAGE TO BREAK AND HAVING TO REPLACE IT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21418766 ↗
• MalfunctionFeb 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING ANTERIOR CERVICAL FIXATION PROCEDURE. IT WAS REPORTED THAT AT THE TIME OF PLACING THE DEVICE IT WAS OBSERVED THAT THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WAS A PATIENT INVOLVED. THE PATIENT WAS HAVING THE IMPLANT PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362289 ↗
• MalfunctionJan 30, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A C4-C5 ACDF PROCEDURE. IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE CAGE BROKE. THE DEVICE WAS NEVER IMPLANTED. NO PATIENT INJURY / COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272290 ↗
• MalfunctionNov 1, 2024Break; Break

  INFORMATION WAS RECEIVED FROM DISTRIBUTOR VIA HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE CAGE WAS BROKEN DURING PROCEDURE. THERE WERE NO PATIENT SYMPTOMS REPORTED AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20587862 ↗
• MalfunctionJun 17, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED: THE PROCEDURE PERFORMED WAS ANTERIOR CERVICAL DISCECTOMY AND FUSION. NO FRAGMENT OF THE IMPLANT REMAINING IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19545225 ↗
• MalfunctionJun 13, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT SURGEON PERFORMED A COMBINED ANTERIOR AND POSTERIOR CERVICAL FRACTURE AND DISLOCATION REDUCTION AND INTERNAL FIXATION. AFTER POSTERIOR SCREW ROD FIXATION WAS PERFORMED FIRST, ANTERIOR CERVICAL PRODUCT STAND ALONE WAS USED IN THE ANTERIOR APPROACH. WHEN HOLDING THE FUSION CAGE WITH A HOLDER TOOL AND INSERTING IT INTO THE INTERVERTEBRAL SPACE, TAP THE FUSION CAGE TOWARD THE POSTERIOR EDGE OF THE VERTEBRAL BODY TO INSERT. A BREAK OCCURRED. AFTER REPLACING THE FUSION CAGE, IT BROKE AGAIN WHEN THE SURGEON HIT IT. WHEN REPLACING THE THIRD FUSION CAGE, IT WAS IMPLANTED NORMALLY AND COMPLETED THE SURGERY. THIS SURGERY CAUSED TWO SCREWS TO DEFORM AND TWO CAGES TO BREAK. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19527106 ↗
• MalfunctionJun 7, 2024Crack; Crack

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAGE IN AN ACDF FOR CERVICAL SPONDYLOSIS. IT WAS REPORTED THAT THE SURGEON FOUND THAT THE FUSION CAGE WAS CRACKED WHEN IMPLANTING. THE CRACKED FUSION CAGE COULD NO LONGER BE USED. AN ATTEMPT WAS MADE TO IMPLANT THE CAGE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE CAGE WAS NOT CRACKED WHEN THE PRODUCT WAS OPENED FROM THE BOX FOR THE FIRST TIME. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19482335 ↗
• MalfunctionJun 6, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL ARTHODESIS FOR AN CERVICAL HERNIA. IT WAS REPORTED THAT THE CAGES HAD THEIR STRUCTURE DAMAGED WHEN THEY WERE INSERTED AND IMPACTED ON THE PATIENT. TWO OF THEM STILL ARE IN THE PATIENT. THERE WAS NO SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475060 ↗
• MalfunctionJun 6, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL ARTHODESIS FOR AN CERVICAL HERNIA. IT WAS REPORTED THAT THE CAGES HAD THEIR STRUCTURE DAMAGED WHEN THEY WERE INSERTED AND IMPACTED ON THE PATIENT. TWO OF THEM STILL ARE IN THE PATIENT. THERE WAS NO SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475052 ↗
• MalfunctionDec 26, 2023Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING CAGE CERVICAL DIVERGENCE. IT WAS REPORTED THAT THE DOCTOR PLACED THE CAGE WITH THE GUIDE, AND THEN TRIED TO ALIGN IT BY IMPACTING THE CAGE IN AN IMPROVISED WAY, THUS BREAKING IT. THERE WERE NO PROBLEMS WITH THE PATIENT. THE BROKEN CAGE WAS REMOVED AND A NEW ONE WAS PLACED IN PLACE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18395791 ↗