CD Horizon™ ModuLeX™ Spinal System 559200007Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20763000435695), received between Feb 3, 2025 and Jul 9, 2026 — classified as 1 injury, 3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2026Material Fragmentation; Product Quality Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25758946 ↗
• MalfunctionApr 28, 2026Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WITH CLINICAL ID (B)(6) AND STUDY ID (B)(6) HAVING SPINAL THERAPY FOR STENOSIS. IT WAS REPORTED THAT THERE IS BILATERAL PEDICLE SCREW LUCENCY. 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 25013646 ↗
• MalfunctionMay 4, 2025Break; Mechanics Altered; Break; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR FUSION SPINAL THERAPY FOR STENOSIS. LEVELS IMPLANTED T8-PELVIS. IT WAS REPORTED THAT THE TULIP IMPLANT WAS NOT ABLE TO BE LOADED ONTO THE DEVICE THAT ATTACHES THE TULIP TO THE SHANK OF THE SCREW, AND THE IMPLANT COULD NOT BE PLACED ON THE SHANK. INSTRUMENT OR IMPLANT BREAKAGE OCCURRED, BUT NO FRAGMENTS REMAINED IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21956783 ↗
• InjuryFeb 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO HAD TLIF (L3-S1). IT WAS REPORTED THAT TULIP HEAD ON THE LEFT L3 SCREW WAS COMPLETELY DETACHED FROM THE SHANK. REVISION SURGERY WAS PERFORMED TO EXPLANT THE DAMAGED SCREW. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21291812 ↗