CD HORIZON® Spinal System 76446540Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885074134758), received between Jan 2, 2025 and Jan 2, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionJan 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM A REGULATORY BODY VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT THORACOLUMBAR FUSION, POSTERIOR APPROACH FOR LUMBAR SPONDYLOLISTHESIS WITH SPINAL STENOSIS. IT WAS REPORTED THAT WHEN THE SCREWS WERE IMPLANTED, THE TAILS OF 3 SCREWS FELL OFF. THEN THE SCREWS WERE SCREWED OUT, AND THE SCREW OF A NEW MODEL WERE UNIFORMLY REPLACED AND RE-IMPLANTED, WHICH PROLONGED THE OPERATION TIME AND INCREASED THE PAIN OF THE PATIENT. THE OPERATION WAS EXTENDED FOR 10 MINUTES, THE PATIENT DID NOT CAUSE SERIOUS INJURY, THE SCREW WAS REPLACED DURING THE OPERATION, AND THE OPERATION WAS SUCCESSFULLY COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Intraoperative Pain

  MAUDE report 21056810 ↗

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-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-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-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
• 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