Divergence Anterior Cervical Fusion SystemRecalls & reported problems across all models

We found 15 models of Divergence Anterior Cervical Fusion System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 179 adverse event reports in the FDA's MAUDE database, received between Jan 2, 2017 and Sep 24, 2026 — classified as 9 injuries, 170 malfunctions.

The most frequently reported specific device problem is “Break” (128 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Divergence Anterior Cervical Fusion System problems

Divergence Anterior Cervical Fusion System models

15 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Divergence® Anterior Cervical Fusion System G6626525

  Intervertebral fusion device with integrated fixation, cervical
  75 reports
• Divergence® Anterior Cervical Fusion System G6626526

  Intervertebral fusion device with integrated fixation, cervical
  49 reports
• Divergence® Anterior Cervical Fusion System G6626746

  Intervertebral fusion device with integrated fixation, cervical
  21 reports
• Divergence® Anterior Cervical Fusion System G6626745

  Intervertebral fusion device with integrated fixation, cervical
  9 reports
• Divergence® Anterior Cervical Fusion System G6626527

  Intervertebral fusion device with integrated fixation, cervical
  5 reports
• Divergence® Anterior Cervical Fusion System G6626747

  Intervertebral fusion device with integrated fixation, cervical
  4 reports
• Divergence® Anterior Cervical Fusion System G6620525

  Intervertebral fusion device with integrated fixation, cervical
  4 reports
• Divergence® Anterior Cervical Fusion System G6626748

  Intervertebral fusion device with integrated fixation, cervical
  2 reports
• Divergence® Anterior Cervical Fusion System G6620526

  Intervertebral fusion device with integrated fixation, cervical
  2 reports
• Divergence® Anterior Cervical Fusion System G6620745

  Intervertebral fusion device with integrated fixation, cervical
  2 reports
• Divergence® Anterior Cervical Fusion System G6623515

  Intervertebral fusion device with integrated fixation, cervical
  2 reports
• Divergence® Anterior Cervical Fusion System G6620746

  Intervertebral fusion device with integrated fixation, cervical
  1 report
• Divergence® Anterior Cervical Fusion System 6620812

  Intervertebral fusion device with integrated fixation, cervical
  1 report
• Divergence® Anterior Cervical Fusion System G6623511

  Intervertebral fusion device with integrated fixation, cervical
  1 report
• Divergence® Anterior Cervical Fusion System G6623513

  Intervertebral fusion device with integrated fixation, cervical
  1 report

Recent Divergence Anterior Cervical Fusion System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Fracture

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having Spinal therapy. It was reported that during spinal surgery involving placement of an interbody implant and screws, the interbody implant was tamped to achieve appropriate positioning before placement of the left-sided screw. During attempted placement of the left-sided screw, the locking mechanism appeared irregular. The surgeon removed the screw and interbody implant, and the interbody implant was observed to be fractured near the center locking mechanism. The interbody implant was replaced with one replacement product. No patient complications have been reported as a result of this event. Additional information was received that there was no issue to the screw in this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880732 ↗
• MalfunctionJun 3, 2026Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SPACER BEING USED IN SPINAL THERAPY. IT WAS STATED THAT THE DEVICE FRACTURED DURING IMPLANTATION. PATIENT INVOLVED DID NOT EXPERIENCE ANY SYMPTOMS AS A CONSEQUENCE OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED AS DURING IMPLANTATION, THE FUSION CAGE FRACTURED. AFTER THIS OCCURRED, IT WAS IMMEDIATELY REMOVED AND THERE WAS A LESS THAN 60 MINS DELAY IN THE PROCEDURE. IT WAS STATED THAT THE PROCEDURE BEING CARRIED OUT WAS FRACTURE SURGERY WITH PROSTHESIS IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25371425 ↗
• InjuryApr 16, 2026Osseointegration Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT HAVING POSTERIOR CERVICAL LAMINECTOMY. IT WAS REPORTED THAT IMPLANTS WERE USED DURING AN INDEX POSTERIOR SPINAL FIXATION AND FUSION FROM SKULL TO C7. AN ADDITIONAL SPINAL REVISION SURGERY WAS PERFORMED BECAUSE OF FUSION FAILURE. NO ASSESSMENT OF PRODUCT, THERAPY, OR PROCEDURE RELATEDNESS WAS MADE BY THE INVESTIGATOR, SPONSOR, OR CEC.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24893787 ↗
• MalfunctionMar 26, 2026Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT A ZERO-PROFILE INTERBODY FUSION DEVICE FRACTURED. THE SCREW HOLE OFTHE FUSION DEVICE WAS DAMAGED, WHICH ALLOWED THE SCREW TO ADVANCE INTO THE VERTEBRAL BODY AND PREVENTED SUCCESSFUL FIXATION. AS A RESULT, THE DEVICE WAS COMPLETELY EXPLANTED AND REPLACED DURING THE PROCEDURE. 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 24696977 ↗
• MalfunctionMar 10, 2026Break; Mechanical Jam

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SMALL PIECE ON THE TOP OF THE CAGE BROKE OFF AND GOT STUCK UNDER THE SCREW. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS NO MALFUNCTION WITH THE SCREW, AND THERE WERE NO PLANS FOR EXPLANT SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24555082 ↗
• MalfunctionJan 28, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A INSERTER USED FOR SPINAL THE RAPY. IT WAS REPORTED THAT DURING ROUTINE INSPECTION OF THE INSTRUMENT SET, THE INSERTER WOULD NOT FULLY SIT INSIDE THE FREEHAND INSERTER SLEEVE AND WOULD NOT SLIDE THROUGH COMPLETELY. ADDITIONALLY, THE THREADS OR SHAFT MAY HAVE BEEN DAMAGED OR BENT. 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 24197858 ↗
• 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 ↗
• MalfunctionDec 30, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING AN EVENT WHICH OCCURRED DURING A C4-C5, C5-C6 ACDF PROCEDURE. IT WAS REPORTED THAT TWO IMPLANTS (CAGES) BROKE/CRACKED AT THE SAME PLACE ON THE IMPLANT (LOCKING AREA). 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 23921650 ↗
• MalfunctionDec 30, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING AN EVENT WHICH OCCURRED DURING A C4-C5, C5-C6 ACDF PROCEDURE. IT WAS REPORTED THAT TWO IMPLANTS (CAGES) BROKE/CRACKED AT THE SAME PLACE ON THE IMPLANT (LOCKING AREA). 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 23921623 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 26, 2025Break; Use of Device Problem; Break; Use of Device Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE DISTRIBUTOR RECEIVED A COMPLAINT REGARDING A SPINAL SURGERY PERFORMED ON PATIENT. THE EXTERNAL TECHNICIAN INFORMED THAT, WHILE PLACING THE INDEPENDENT CAGE 17MM X 14MM X 6MM, EXPERIENCED A FRACTURE OF THE DEVICE DURING THE SCREW INSERTION PROCESS. THE TECHNICIAN OBSERVED THAT THE PHYSICIAN OVERTIGHTENED THE SCREW AND ALSO MENTIONED THAT THE SCREWDRIVER USED DID NOT HAVE A TORQUE LIMITER. THE PRODUCT WAS RETURNED TO THE COMPANY AFTER THE SURGERY AND WILL BE STORED IN THE REJECTED PRODUCTS WAREHOUSE UNTIL THE IMPORTER RETRIEVES IT FOR FURTHER ANALYSIS. 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 22892494 ↗
• 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 ↗
• MalfunctionAug 7, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING POSTERIOR AND ANTERIOR ARTHRODESIS. IT WAS REPORTED THAT THE DEVICE HAS BROKEN. 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 22735871 ↗
• 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 ↗

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