CD HORIZON® Spinal System 55840007560Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169004375), received between Dec 29, 2016 and Dec 16, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• 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 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 23816100 ↗
• InjuryFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INFORMATION WAS RECEIVED FROM A CLINICAL STUDY WITH CLINICAL PATIENT ID: (B)(6). PROCEDURE: STENOSIS AT L2-3 AND HEMATOMA THAT WAS COMPRESSING THE L3-S1 THECAL SAC IN THE REGION OF PRIOR DECOMPRESSION. ALL OF THE THECAL SAC WAS FULLY DECOMPRESSED WITH NO REMAINING HEMATOMA. LEVELS INVOLVED IN ADDITIONAL SURGICAL PROCEDURE: L2/L3, L3/L4, L4/L5, L5/S1. TREATMENT GROUP: GROUP 1 - INFUSE 4.2 + MASTERGRAFT + LOCAL BONE IT WAS REPORTED THAT THERE WAS VACUUM DISC AT L2-3 : SEEN ON CT SCAN (B)(6) 2020. THE PATIENT HAS MEDICAL HISTORY OF PREVIOUS LUMBAR SURGERY : SURGERY 1: DATE OF SURGERY: (B)(6) 2015, TYPE OF SPINAL SURGERY: LAMINECTOMY, LEVEL(S): L2/L3, DETAILS: L2-3 DECOMPRESSION. PRIMARY DIAGNOSTIC INDICATION : ALL OTHER DIAGNOSTIC INDICATIONS: STENOSIS WITH DOCUMENTED PREOPERATIVE INSTABILITY. PLEASE INDICATE THE NUMBER OF CONSECUTIVE LEVELS (FROM L2-S1) THE SUBJECT WILL HAVE TREATED: 3 LEVELS. PATIENT DETAILS: RANDOMIZATION ASSIGNMENT: 4.2MG OF RHBMP-2 RANDOMIZATION DATE: (B)(6) 2019 NUMBER OF LEVELS TO BE TREATED: 3LEVELS PREGNANT SINCE LAST VISIT 6_WEEKS: HAS THE SUBJECT BECOME PREGNANT SINCE LAST VISIT: NA DATE OF VISIT: (B)(6) 2020 PREGNANT SINCE LAST VISIT 3_MONTHS: HAS THE

  Patient problems: Intervertebral Disc Compression or Protrusion

  MAUDE report 11363669 ↗
• MalfunctionDec 29, 2016Break; Break

  IT WAS REPORTED DURING SURGERY, THE PEDICLE SCREW BROKE WHEN THE SURGEON TRIED TO REMOVE IT. THE PRODUCT CAME IN CONTACT WITH PATIENT. FRAGMENTS OF THE BROKEN SCREW REMAINED IN PATIENT. PATIENT COMPLICATIONS ARE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6212075 ↗

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.