CD HORIZON® Spinal System 1555501060Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169081260), received between Dec 31, 2024 and May 29, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K113174); they may or may not involve this specific model.

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 18, 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.

• InjuryMay 29, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST AN UNKNOWN L4-S1 SPINAL PROCEDURE IN A PATIENT DIAGNOSED WITH LUMBAR STENOSIS. IT WAS REPORTED THAT THE ROD WAS BROKEN POST SURGERY. PATIENT HAD PAIN AND PSEUDOARTHROSIS. THE ROD WAS EXPLANTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 22103609 ↗
• InjuryMay 29, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST AN UNKNOWN L4-S1 SPINAL PROCEDURE IN A PATIENT DIAGNOSED WITH LUMBAR STENOSIS. IT WAS REPORTED THAT THE ROD WAS BROKEN POST SURGERY. PATIENT HAD PAIN AND PSEUDOARTHROSIS. THE ROD WAS EXPLANTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 22103593 ↗
• InjuryJan 14, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST AN UNKNOWN L4-S1 SPINAL PROCEDURE IN A PATIENT DIAGNOSED WITH LUMBAR STENOSIS. IT WAS REPORTED THAT THE ROD WAS BROKEN POST SURGERY. PATIENT HAD PAIN AND PSEUDOARTHROSIS. THE ROD WAS EXPLANTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 21147102 ↗
• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE STATING THE TARGET LEVELS WERE L4/L5 AND L5/S1. INVESTIGATOR ASSESSMENT STATES, THE ADVERSE EVENT WAS RELATED TO PROCEDURE/DEVICE. POSSIBLE RELATED TO PROCEDURE, POSTERIOR LUMBAR FUSION GRAFTING MATERIAL, POSTERIOR FIXATION AND INTERBODY FUSION. SPONSOR ASSESSMENT STATES, POSSIBLY RELATED TO POSTERIOR LUMBAR FUSION GRAFTING MATERIAL, POSTERIOR FIXATION, INTERBODY FUSION AND NOT RELATED TO SURGICAL FUSION. SPONSOR ASSESSMENT (OC MUO): CEC ASSESSMENT - CAUSAL RELATED TO THE PROCEDURE. POSSIBLE RELATIONSHIP TO POSTERIOR LUMBAR FUSION GRAFTING, POSTERIOR FIXATION AND INTERBODY FUSION. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21046302 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113174. One submission often covers many models, so check the product and lot details in each record.

• Z-2603-2018 · Jul 9, 2018 · Terminated
  Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.