Divergence® Anterior Cervical Fusion System G6626746Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00643169337473), received between Feb 19, 2017 and Jun 3, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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 ↗
• MalfunctionJul 23, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE STATING THE LEVELS INVOLVED WERE C5-C6. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574925 ↗
• MalfunctionFeb 13, 2025Positioning Failure; Device Handling Problem; Positioning Failure; Device Handling Problem

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SURGEON APPROPRIATELY PLACED IMPLANT INTO DISC SPACE USING FREEHAND INSERTER. UNFORTUNATELY HE DECIDED TO REMOVE THE INSERTER AFTER PLACEMENT, AND PROCEEDED TO DRILL THROUGH CAGE HOLES, WITHOUT ANY GUIDE HOLDING IMPLANT IN PLACE. HE SUGGESTED THE CAGE WAS SHIFTING AND DECIDED TO PLACE ONE SCREW THROUGH THE CAGE TO STABILIZE AND HE PROCEEDED TO DRILL THE SECOND HOLE, AGAIN WITH NO GUIDE HOLDING IMPLANT STABLE. CAGE SUNK DOWN INTO THE SPINAL CANAL. HE WAS ABLE TO RETRIEVE IT AND REMOVE SCREW. HE DECIDED TO USE THE DIVERGENCE CAGE AS ONLY A SPACER, AND DECIDED TO PLATE THE SPACE WITH SCREWS. SURGEON CHOSE TO USE A STAND ALONE DEVICE (DIVERGENCE) DUE TO THE FACT THAT THE PATIENT HAD ADJACENT LEVEL DISEASE, AND DID NOT WANT TO REMOVE OLD HARDWARE. 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 21372452 ↗
• MalfunctionFeb 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING DISCECTOMY AND CERVICAL ARTHRODESIS WITH SELF-SUSTAINING C5-C6 AND C6-C7 CAGE FOR C5-C6 AND C6-C7 DEGENERATIVE INSTABILITY, BILATERAL FORAMINAL STENOSIS. IT WAS REPORTED THAT DURING SURGERY WHEN PUTTING THE SCREW, THE CAGE BROKE. 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 21301429 ↗
• MalfunctionFeb 3, 2025Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DIVERGENCE CAGE WAS FOUND TO BE BROKEN BEFORE IMPLANTATION. AFTER CONFIRMING THE SIZE, OPENED THE PACKET AND ATTEMPTED TO FIX THE CAGE IN THE INSTRUMENT FOR IMPLANTATION, AT WHICH POINT IT WAS DISCOVERED TO BE BROKEN. THERE WAS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21292547 ↗
• MalfunctionSep 24, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING UNKNOWN SPI NAL THERAPY. IT WAS REPORTED THAT THE CAGE BROKE DURING IMPLANTATION. THERE WAS NO PATIENT SYMPTOM REPORTED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20290436 ↗
• MalfunctionAug 22, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED THAT DELAY IN THE PROCEDURE WAS 5 MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20025090 ↗
• MalfunctionAug 21, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED THAT DELAY IN THE PROCEDURE WAS 5 MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20010512 ↗
• MalfunctionMay 16, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL/ DISTRIBUTOR VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAGE IN AN ANTERIOR CERVICAL DECOMPRESSION AND FUSION FOR A CERVICAL DISC REMOVAL, BONE GRAFTING, FUSION AND INTERNAL FIXATION. IT WAS REPORTED THAT THE STANDALONE FUSION CAGE BROKE DURING SURGERY. THE CAGE WAS REPLACED PROMPTLY DURING SURGERY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE CAGE WAS EXPLANTED. THERE WAS NO SUSPECTED MANUFACTURING ISSUE FOUND 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 19329269 ↗
• MalfunctionMar 28, 2023Fracture; Fracture

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF A PATIENT UNDERGOING ANTERIOR CERVICAL DISCECTOMY AND FUSION. IT WAS REPORTED THAT, THE CAGE WAS FRACTURED NEAR SCREW HOLE UPON FINAL BONE SCREW INSERTION. FRACTURED IMPLANT WAS REMOVED FROM PATIENT BODY AND REPLACED WITH A NEW IMPLANT. THERE WAS A DELAY OF 5 MINUTES REPORTED AS A RESULT. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16626014 ↗
• MalfunctionFeb 24, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPINAL DEVICE USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT CAGE WAS BROKEN WHILE INSERTING. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THIS EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THEY TRIED TO IMPLANT THE CAGE BUT EXPLANTED ON THE SAME DATE DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16434120 ↗
• MalfunctionSep 5, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL FUSION DUE TO C3-4 DISC HERNIATION. IT WAS REPORTED THAT AFTER THE FUSION WAS INSTALLED, DURING THE SCREW IMPLANTATION PROCESS, WHEN THE SCREW WAS SCREWED IN, THE FUSION WAS BROKEN. DURING THE IMPLANTATION OF THE FUSION DEVICE, IT WAS USUALLY LIGHTLY KNOCKED INTO THE INTERVERTEBRAL SPACE. DURING THE KNOCKING, IT WAS FOUND THAT THE FUSION DEVICE/SPACER WAS BROKEN. 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 15355121 ↗
• MalfunctionJul 29, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR VIA A MANUFACTURER REPRESENTATIVE REGARDING AN IMPLANT USED FOR CERVICAL DISCECTOMY. IT WAS REPORTED THAT THE IMPLANT RUPTURED DURING SURGERY. IMPLANT CAME IN CONTACT WITH THE PATIENT. IMPLANT BROKE DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127459 ↗
• MalfunctionMay 13, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. PROCEDURE OR THERAPY PERFORMED WAS C6-C7 ACDF. IT WAS REPORTED THAT THE CAGE WAS DAMAGED DURING INSERTION. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. CAGE WAS BROKEN & BROKEN FRAGMENTS WERE RETRIEVED FROM THE PATIENT BODY. PRODUCT CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14389262 ↗
• MalfunctionApr 7, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH STENOSIS; AND UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION. INTRA-OP, AFTER THE CAGE WAS PLACED AND THE SCREWS WERE INSERTED, THE CAGE WAS NOTICED TO BE BROKEN. ACCORDING TO THE SALES REP, THE IMPLANT MIGHT HAVE BROKEN DUE TO THE FORCE APPLIED BY THE SURGEON WHILE TRYING TO PUSH IT DEEPER. THE IMPLANT AND THE SCREWS WERE THEN REMOVED; AND ANOTHER IMPLANT WAS USED TO COMPLETE THE PROCEDURE. NO FRAGMENT OF THE BROKEN CAGE REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9933696 ↗
• 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 6867807 ↗
• 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 6342639 ↗
• 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 6342637 ↗