CD HORIZON® Spinal System 55840009550Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169005402), received between Apr 20, 2021 and Apr 20, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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

• MalfunctionApr 20, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING A PROCEDURE OF ANTERIOR LUMBAR INTERBODY FUSION THEN A POSTERIOR FUSION REVISION AND THE LEVELS IMPLANTED WERE L3 - ILIUM. IT WAS REPORTED THAT, THE SCREW THAT BROKE STAYED IN THE PATIENT. BUT ALL PARTS OF BROKEN SCREWDRIVER WERE RETRIEVED. THE BROKEN SCREW FRAGMENT WAS REMAINED IMPLANTED IN PATIENT. THE SCREW WAS BROKEN WHEN TRYING TO INSERT. THE BROKEN SCREW WAS IMPLANTED IN PATIENT AND THERE WERE NO PLANS TO RETRIEVE OR REMOVE THE BROKEN SCREW. THE PROCEDURE IS SCHEDULED A/P L4- ILIUM REVISION OF L5-S1. THERE WAS NO DELAY IN PROCEDURE IN OCCURRED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11692370 ↗

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.