CD HORIZON® Spinal System 55410005545Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169074521), received between Jun 9, 2022 and Jun 9, 2022 — 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 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 9, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A L 3/L4/L5 TWO-LEVEL LUMBAR POSTERIOR LUMBAR FIXATION PROCEDURE IN A PATIENT DIAGNOSED WITH FRACTURE OF THE L3 VERTEBRA DUE TO A FALL FROM HEIGHT. IT WAS REPORTED THAT THE IMPLANTED SCREW IS BROKEN INSIDE THE PATIENT AND THE PATIENT EXPERIENCING LUMBAR PAIN. HCP IS EVALUATING THE REMOVAL OF DAMAGED SCREW. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 14640737 ↗

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.