CD HORIZON® Spinal System 75447550Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885074134222), received between Sep 20, 2019 and Sep 20, 2019 — classified as 1 injury.

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

4 other recalls cover devices cleared under the same FDA submission (K042025); 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.

• InjurySep 20, 2019Break; Break

  IT WAS REPORTED THAT POST-OPERATIVELY, THE SCREW THE S1 AREA HAD BROKEN UNDER THE TULIP HEAD WHERE THE SCREW SHAFT BEGINS AROUND S1. THE PATIENT UNDERWENT ANOTHER SURGERY FOR REMOVAL OF PEDICLE SCREW SYSTEM, L5-S1 IMPLANTATION USING LEGACY SCREWS, PLACEMENT OF LEGACY ILIAC WING SCREWS, LATERAL CONNECTORS. THE OLD HARDWARE WAS REPLACED WITH NEW INSTRUMENTATION. THE PHYSICIAN USED THE O-ARM AND STEALTH TO PLACE NEW PEDICLE SCREWS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9097180 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042025. One submission often covers many models, so check the product and lot details in each record.

• Z-0464-2012 · Nov 30, 2011 · Terminated
  CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD THREAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X0809439, Rx only, Medtronic Sofamor Danek USA, 1800
• Z-0465-2012 · Nov 30, 2011 · Terminated
  CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X1010484, Rx only, Medtronic Sofamor Danek USA, 1800 Py
• Z-2878-2011 · Jun 28, 2011 · Terminated
  ATLANTIS (R) Self-Tapping Variable Angle Screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization and stabilizat
• Z-2875-2011 · Jun 28, 2011 · Terminated
  CD HORIZON (R) LEGACY (TM) MAS, REF 75445540, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization a