CD HORIZON® Spinal System 55740107545Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169052116), received between Mar 20, 2024 and Mar 23, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 16, 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.

• InjuryMar 23, 2026Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION SPINAL THERAPY AT L3/4 AND L4/5. IT WAS REPORTED THAT THE IMPLANT BACKED OUT AT THE L4/5 LEVEL. THERE WAS A LACK OF SOLID FUSION AT THE AFFECTED LEVEL. THE PATIENT WAS SCHEDULED FOR ADDITIONAL SURGERY TO REMOVE THE IMPLANT AT A LATER DATE. IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE THAT THE REVISION SURGERY PERFORMED ON (B)(6) 2026. PATIENT HAD LINGERING BACK PAIN POST OPERATIVELY. PATIENT HAD A PRE-OPERATIVE DIAGNOSIS OF LUMBAR RADICULOPATHY NEEDING A L3-L5 FUSION. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE THAT THE 2 SCREWS WERE LOOSENED AND THEY WERE EXPLANTED ON THE REVISION SURGERY PERFORMED ON (B)(6) 2026.

  Patient problems: Back pain; Nonunion/Delayed-union Bone Fracture

  MAUDE report 24659802 ↗
• InjuryMar 23, 2026Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION SPINAL THERAPY AT L3/4 AND L4/5. IT WAS REPORTED THAT THE IMPLANT BACKED OUT AT THE L4/5 LEVEL. THERE WAS A LACK OF SOLID FUSION AT THE AFFECTED LEVEL. THE PATIENT WAS SCHEDULED FOR ADDITIONAL SURGERY TO REMOVE THE IMPLANT AT A LATER DATE. IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. 2026-MAR-03_E1 (REP): ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE THAT THE REVISION SURGERY PERFORMED ON (B)(6) 2026. PATIENT HAD LINGERING BACK PAIN POST OPERATIVELY. PATIENT HAD A PRE-OPERATIVE DIAGNOSIS OF LUMBAR RADICULOPATHY NEEDING AL3-L5 FUSION. 2026-MAR-04_E2 (REP): ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE THAT THE 2 SCREWS WERE LOOSENED AND THEY WERE EXPLANTED ON THE REVISION SURGERY PERFORMED ON (B)(6) 2026.

  Patient problems: Back pain; Nonunion/Delayed-union Bone Fracture

  MAUDE report 24659795 ↗
• MalfunctionMar 20, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH A SCREW IN AN L4-S1 PLF. IT WAS REPORTED THAT THE L4 SCREW BROKE AND IS STILL IN PATIENT. NO ADDITIONAL SURGERY HAS BEEN SCHEDULED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18938826 ↗

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.