CD Horizon™ ModuLeX™ Spinal System 559200098Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20763000848556), received between May 26, 2026 and Sep 23, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having posterior spinal fusion for adult degenerative disc disease at L5-S1 levels. It was reported that during a procedure, the set screw collar broke off prior to being fully seated. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865377 ↗
• MalfunctionMay 26, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT ONE OF THE FOUR TULIPS AFTER APPLIED TO THE SCREW WOULD NOT THREAD ONTO THE MT25 MODULEX NAV DRIVER. AFTER THE CASE IT WAS ABLE TO GET IT TO LOAD BUT IT WAS NOT EASY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED AS THE MT25 MODULEX NAV DRIVER DID NOT HAVE ANY MALFUNCTION/ALLEGATION. THE DRIVER HAD WORKED PERFECTLY FOR 5 OF THE OTHER 6 SCREWS THAT WERE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273825 ↗