CD HORIZON® Spinal System 76446535Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885074134734), received between Sep 8, 2020 and Sep 8, 2020 — 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 18, 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 8, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH LUMBAR SPINAL STENOSIS INVOLVED IN SPINAL THERAPY. IT WAS REPORTED THAT POST-OP, SCREW ROD BROKE AND FRAGMENTS LEFT IN THE PATIENT. THERE WERE PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. PATIENT SYMPTOM-OSPHYALGIA (PAIN IN THE LUMBAR REGION) WAS REPORTED. ADDITIONAL INFORMATION RECEIVED THAT LUMBAR 5 AND SACRAL 1 SCREWS WERE BROKEN. PATIENT ACHIEVED SOLID FUSION. PATIENT IS ALIVE. ON (B)(6) 2020, RECEIVED ADDITIONAL INFORMATION THAT REVISION SURGERY PERFORMED TO THE PATIENT. THE IMPLANTATION HAS BEEN REMOVED. HOWEVER, ONLY THE TIP SIDE OF THE BROKEN SCREW HAS BEEN REMOVED, AND SOME SCREW ROD REMAINED IN THE PATIENT'S BODY.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; Pain

  MAUDE report 10501551 ↗

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