CD HORIZON® Spinal System 55410005550Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169074514), received between Dec 2, 2022 and Dec 2, 2022 — classified as 1 injury.

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.

• InjuryDec 2, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR FIXAT ION, COMPRESSION FROM L3 TO L5 FOR FRACTURE REDUCTION AT L4 FOR FRACTURE DUE TO PARAGLIDING FALL. LEVELS IMPLANTED: 2 IT WAS REPORTED THAT THE DEVICE BROKE. NO FRAGMENT WAS LEFT IN THE PATIENT. THE PATIENT HAD PAIN. ADDITIONAL SURGERY WAS PERFORMED FOR REMOVAL OF THE SCREWS. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 15902956 ↗

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.