DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System 2150135Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169502413), received between May 22, 2017 and Nov 19, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Product Quality Problem; Product Quality Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT THE SCREW IS MANUFACTURED POORLY. THE SCREW HAS SHARDS OF METAL STICKING OUT OF THE SCREW SHAFT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23590806 ↗
• MalfunctionMay 22, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, SCREW MIGRATED. PATIENT HAD POOR BONE QUALITY. PATIENT COMPLICATIONS WERE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6580883 ↗
• MalfunctionMay 22, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, SCREW MIGRATED. PATIENT HAD POOR BONE QUALITY. PATIENT COMPLICATIONS WERE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6580882 ↗