CD Horizon™ ModuLeX™ Spinal System NAV5597413Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000845001), received between Jul 18, 2024 and Aug 29, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 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.

• MalfunctionAug 29, 2025Break; Mechanics Altered; Break; Mechanics Altered

  INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE OUTER COLLAR WAS FOUND TO BE LOOSE ON THE INSTRUMENT. ADDITIONALLY, THE WASHER HAD BROKEN AND HAD BECOME LOOSE AFTER MANY USES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920439 ↗
• MalfunctionJun 5, 2025Crack; Noise, Audible; Crack; Noise, Audible

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED ON PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO ADVANCE THE SCREW AFTER HEARING A POP OR CRACK. THE DRIVER WAS REMOVED FROM THE SCREW SHANK, AND A BACKUP DRIVER WAS USED TO COMPLETE THE SCREW PLACEMENT. THE DRIVER WAS THEN REMOVED FROM THE STERILE FIELD, AND WASHED. THE PRODUCT HAD BEEN PREVIOUSLY USED MANY TIMES. 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 22148233 ↗
• MalfunctionJul 18, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT THE DRIVER TIP IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19770624 ↗