CD HORIZON® Spinal System 1553201050Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169015944), received between Aug 7, 2023 and Mar 26, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THER APY. IT WAS REPORTED THAT THE FDA TAB OF THE DEVICE HAS BROKEN. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21695736 ↗
• MalfunctionMar 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE FDA TAB OF THE DEVICE HAS BROKEN. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21695434 ↗
• MalfunctionMar 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THER APY. IT WAS REPORTED THAT THE FDA TAB OF THE DEVICE HAS BROKEN. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21694979 ↗
• MalfunctionMar 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THER APY. IT WAS REPORTED THAT THE FDA TAB OF THE DEVICE HAS BROKEN. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21694815 ↗
• MalfunctionMar 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE FDA TAB OF THE DEVICE HAS BROKEN. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21694780 ↗
• MalfunctionMar 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THER APY. IT WAS REPORTED THAT THE FDA TAB OF THE DEVICE HAS BROKEN. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21694660 ↗
• MalfunctionMar 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE FDA TAB OF THE DEVICE HAS BROKEN. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21694648 ↗
• MalfunctionMar 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THER APY. IT WAS REPORTED THAT THE FDA TAB OF THE DEVICE HAS BROKEN. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21694638 ↗
• MalfunctionJan 5, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE FDA TAB OF THE DEVICE HAS BROKEN. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21076182 ↗
• InjuryAug 7, 2023Break; Break

  INFORMATION WAS RECEIVED FROM VARIOUS SOURCES (HEALTH CARE PROFESSIONAL, RISK MANAGER, REGULATORY BODY) VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH ROD SCREW. IT WAS REPORTED THAT BOTH IMPLANTS WERE BROKEN CAUSING A SCHEDULED RETURN TO THE OPERATING ROOM FOR REMOVAL OF HARDWARE. THE ROD WAS IMPLANTED ON (B)(6) 2021 AND EXPLANTED ON (B)(6) 2023. PATIENT COMPLICATIONS WERE UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17468626 ↗

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.