CD HORIZON® Spinal System 55840008590Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169004498), received between Sep 5, 2019 and Dec 16, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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)(6)) 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 TO (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 23817016 ↗
• InjuryOct 27, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL REVISION SURGERY. IT WAS REPORTED THAT, TWO SACRAL SCREWS FRACTURED FROM SURGERY PERFORMED ON (B)(6) 2024. REVISION AND EXPLANT OF IMPLANTS WAS PERFORMED. LEVELS IMPLANTED WERE T10-S1. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23388917 ↗
• InjuryOct 27, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL REVISION SURGERY. IT WAS REPORTED THAT, TWO SACRAL SCREWS FRACTURED FROM SURGERY PERFORMED ON (B)(6) 2024. REVISION AND EXPLANT OF IMPLANTS WAS PERFORMED. LEVELS IMPLANTED WERE T10-S1. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23388281 ↗
• InjurySep 5, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DEGENERATIVE LUMBAR SCOLIOSIS; AND UNDERWENT POSTERIOR SPINAL FUSION AND T10-S2 AND TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5-S1. TWO MONTHS POST OPERATION, THE SCREW IMPLANTED AT S2 BROKE. THE PATIENT ALSO EXPERIENCED PAIN DUE TO THIS EVENT AND FUSION WAS NOT ACHIEVED. HENCE, PATIENT UNDERWENT A REVISION SURGERY, IN WHICH THE BROKEN SCREW WAS REMOVED AND REPLACED WITH A NEW ONE. NO FRAGMENT OF THE BROKEN SCREW REMAINED INSIDE THE PATIENT. THE PATIENT IS CURRENTLY RECOVERING FROM REVISION SURGERY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8964672 ↗

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.