Divergence® Anterior Cervical Fusion System G6626527Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169337435), received between Jun 23, 2017 and Mar 2, 2025 — classified as 1 injury, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2025Break; Mechanics Altered; Break; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR CERVICAL MYELOPATHY. IT WAS REPORTED THAT, IMPLANT ROTATED WHILE BEING IMPLANTED. UPON FURTHER SEATING WITH A TAMP, THE IMPLANT CRACKED. THERE WERE NO FRAGMENTS OF BROKEN CAGE REMAINS IN PATIENT. THE LEVELS PLANNED FOR IMPLANTATION WERE C6-C7 AND THE PROCEDURE OR TECHNIQUE PERFORMED WAS ANTERIOR CERVICAL DISCECTOMY AND FUSION. THERE WERE NO PATIENT SYMPTOMS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21500930 ↗
• MalfunctionFeb 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPACER HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE CAGE BROKE DURING ATTEMPTING TO IMPLANT. WHEN THE SURGEON WAS TAMPING THE CAGE IN PLACE, THE CAGE BROKE INTO MULTIPLE PIECES. SO ALL THE PIECES OF THE CAGE WERE EXPLANTED AND REPLACED WITH A NEW CAGE. THERE WAS A DELAY OF LESS THAN 60 MINS IN THE OVERALL PROCEDURE. PROCEDURE INVOLVED IN THIS EVENT WAS C6-7 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). THERE WAS NO REVISION SURGERY PLANNED/ OCCURRED AS A RESULT OF THE EVENT. 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 21456827 ↗
• MalfunctionOct 7, 2024Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT WHILE MALLETING A TAMP ONTO THE IMPLANT DURING IMPLANTATION, THE CAGE FRACTURED. THE SUPERIOR EDGE OF THE IMPLANT FRACTURED AND THE LOCKING MECHANISM CAME LOOSE AND WAS ABLE TO EXTRACT THE PIECES. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT EVENT OCCURRED DURING NORMAL USAGE OF IMPLANT. PROCEDURE INVOLVED IN THE EVENT WAS C6-7 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20381665 ↗
• MalfunctionSep 6, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT WILL BE USED IN UNKNOWN SPINAL THERAPY FOR CERVICAL DISC HERNIATION. IT WAS REPORTED THAT DURING ANTERIOR CERVICAL FIXATION, A FRACTURE IN THE MEDIAL-LATERAL DIRECTION OF THE CAGE WAS OBSERVED AFTER SCREW INSERTION. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE CRACK WAS FOUND AFTER THE CAGE WAS INSERTED. THE ISSUE OCCURRED DURING NORMAL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20155057 ↗
• InjuryJun 23, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  PRE-OP DIAGNOSIS: CERVICAL HERNIA. PROCEDURE: CERVICAL ANTERIOR FUSION IT WAS REPORTED THAT ON UNKNOWN DATE, POST-OP, THE IMPLANT GOT DEVIATED IN THE PATIENT'S BODY. A REVISION SURGERY WAS PERFORMED FOR FIXATION.

  Patient problems: No Code Available

  MAUDE report 6662687 ↗