CD HORIZON® Spinal System 55410006545Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169073999), received between Feb 20, 2017 and Nov 9, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2020Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR LUM BAR DEGENERATIVE. IT WAS REPORTED THAT ON (B)(6) 2020 THE SCREW SLIPPED DURING THE SOLERA 5.5 SURGERY AND EXPLANTED. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10807585 ↗
• InjuryMay 15, 2017Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNSPECIFIED SPINAL PROCEDURE FOR STABILIZATION OF L4-L5. POST-OP, THE SCREW BROKE AND THE PATIENT UNDERWENT A REVISION SURGERY. THE DISTAL PARTS OF THE SCREWS REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED POST REVISION SURGERY.

  Patient problems: No Code Available

  MAUDE report 6566165 ↗
• InjuryFeb 20, 2017Break; Break

  NO PATIENT COMPLICATIONS WERE REPORTED POST REVISION SURGERY.

  Patient problems: No Code Available

  MAUDE report 6342656 ↗

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.