CD HORIZON® Spinal System 55840007555Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169004368), received between Jul 7, 2025 and Aug 17, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 18, 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.

• InjuryAug 17, 2026Loosening of Implant Not Related to Bone-Ingrowth

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having Fusion revision Spinal therapy for L5 nerve pain to L5/S1. It was reported that solera caps partially backed out from Solera screws in S1. Identified during revision surgery. S1 screws had loosened and needed to be upsized. There were unknown patient symptoms reported. There were no further complications reported regarding the event. Additional information received that there was no patient symptoms reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50270507 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING AN EVENT WHICH OCCURRED POST A CLINICAL STUDY (STUDY ID: (B)(4)) L2-L5 INTERBODY FUSION PROCEDURE IN A PATIENT (PATIENT ID: (B)(6)). PATIENT MEDICAL HISTORY: CHRONIC PAIN, LOWER URINARY TRACT INFECTIOUS DISEASE, OBESITY, PRIMARY OSTEOARTHRITIS OF LEFT HIP, SCOLIOSIS OF LUMBAR SPINE, UNSPECIFIED SCOLIOSIS TYPE. INTERVENTIONS: PATIENT WAS HOSPITALIZED FROM (B)(6) 2025 FOR WOUND IRRIGATION AND DEBRIDEMENT. IT WAS REPORTED THAT PATIENT HAD WOUND INFECTION AFTER SURGERY WITH SPECIFIC SYMPTOMS OF WOUND DISCHARGE AND VISIBLE DEHISCENCE CAUSING WOUND IRRIGATION AND DEBRIDEMENT PROCEDURE WITH HOSPITALIZATION. NO PRODUCT MALFUNCTION REPORTED. AS PER SITE RELATED ASSESSMENT, EVENT WAS POSSIBLY RELATED TO DEVICE AND CAUSALLY RELATED TO STUDY PROCEDURE. MRI WAS DONE WHICH SHOWED FLUID COLLECTION AND SURGICAL WOUND INFECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23816907 ↗
• MalfunctionJul 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL PROCEDURE DATE: (B)(6) 2025 C2-5 POSTERIOR CERVICAL FUSION WITH C3/4 LAMINECTOMY ADDITIONAL PROCEDURE IS NOT RELATED TO SURGICAL CONSTRUCT AND/OR THE STUDY PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410351 ↗

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.