CD Horizon™ ModuLeX™ Spinal System NAV5597651Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000825959), received between Jun 21, 2026 and Jun 21, 2026 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING MULTIPLE DEVICES USED FOR POSTERIOR FUSIONS AND OBLIQUE LATERAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT THE FIVE RATCHET HANDLE DID NOT RATCHET, CAN BE ATTRIBUTED TO NORMAL PRODUCT WEAR AND TEAR, END OF SLEEVE OF THE RATCHET LOCK DRIVER BROKE OFF REMOVING THE INSTRUMENT FROM A SCREW AND END PIECE OF INSERTER SNAPPED OUTSIDE OF PROCEDURE, PART BECAME WORN DOWN AFTER MANY USES. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25571864 ↗