CD Horizon™ ModuLeX™ Spinal System 559200008Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20763000435701), received between May 25, 2023 and Jul 9, 2026 — classified as 2 injuries, 4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2026Material Fragmentation; Product Quality Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, WHILE FINAL TIGHTENING SET SCREW, SURGEON REPORTED FINDING SMALL METAL SHARD AFTER BREAKING SET SCREW OFF. THE PROCEDURE WAS A POSTERIOR LUMBAR FUSION. THE CASE WAS AN L3-5. THE EVENT HAPPENED WHILE FINAL TIGHTENING THE RIGHT L4 SCREW. 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 25759014 ↗
• MalfunctionApr 28, 2026Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT) 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 25013885 ↗
• MalfunctionMar 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN POSTERIOR LUMBAR INTERBODY FUSION THERAPY. LEVELS IMPLANTED WERE L3-S1. IT WAS REPORTED THAT UPON INSERTING THE 6.5 MM OSTEOGRIP SCREWS INTO PROPER AN ATOMIC POSITION, HE BEGAN PLACING THE HEADS ONTO THE SCREWS. AS HE WAS ADVANCING ONE OF THE SCREWS TO A DEEPER DEPTH THE MAS SCREWHEAD FOR 5.5 MM ROD CAME OFF AFTER LOCKING ONTO THE SHANK. HE RETRIEVED THE HEAD FROM THE INCISION AND WAS HANDED A NEW HEAD WHICH WORKED PERFECTLY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PRE-OP INFORMATION GIVEN TO REP WAS: ¿L3-L4, L4-L5 AND L5-S1 BILATERAL LAMINECTOMIES AND FACETECTOMIES, PLIF WITH CAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21580906 ↗
• MalfunctionMar 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4/5 TLIF FOR STENOSIS. IT WAS REPORTED THAT AFTER TEMPORARY TIGHTENING OF THE SET SCREW, AN ATTEMPT WAS MADE TO BREAK OFF THE FINAL TIGHTENING USING A BREAK-OFF SCREWDRIVER. HOWEVER, THE UPPER PART OF THE SET SCREW ON THE LEFT SIDE OF L5 WAS PERFORMED WITHOUT A COUNTER, BUT IT BROKE, AND THE FINAL TIGHTENING COULD NOT BE MADE. THERE WAS LITTLE SPACE BETWEEN THE SCREW HEADS WITH CBT, AND THE COUNTER COULD NOT BE ATTACHED. THERE WAS A DELAY IN THE PROCEDURE BY LESS THAN 60 MINUTES. 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 21503626 ↗
• InjuryMar 28, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAD L4-L5 TLIF. IT WAS REPORTED THAT THE DEVICE HAS BROKEN POST OPERATIVE. BACK PAIN WAS REPORTED TO THE PATIENT. PRODUCT STILL REMAINS IN PATIENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THERE WAS A REVISION SURGERY PLANNED.

  Patient problems: Pain

  MAUDE report 18993672 ↗
• InjuryMay 25, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A SPINAL THERAPY. PROCEDURE: REVISION POSTEROLATERAL FUSION/ REMOVAL OF HARDWARE IT WAS REPORTED THAT SCREWS WERE REMOVED DUE TO IMPLANT MIGRATION POST-OPERATIVE. MODULAR HEAD WAS COLD WELDED TO SHANK UPON EXPLANT CAUSING DIFFICULTY TO REMOVE. NO FRAGMENT REMAINED IN THE PATIENT. 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 17000639 ↗