CD HORIZON® Spinal System 55840006555Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994971777), received between Mar 20, 2018 and Dec 16, 2025 — classified as 3 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 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)(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 ON (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 23816077 ↗
• InjuryNov 11, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD REVISION SURGERY FOR BROKEN HARDWARE DUE TO FALL OUT WHEELCHAIR. IT WAS REPORTED THAT THE PATIENT WAS PARAPLEGIC DUE TO A MOTOR VEHICLE ACCIDENT THAT HAPPENED IN 2020. INITIAL SURGERY (T11-L3) WAS PERFORMED TO REPAIR AND FUSE HIS BACK. PATIENT'S WHEELCHAIR BACK BROKE, CAUSING THE PATIENT TO FALL AND BREAK THEIR HARDWARE IN THEIR BACK. REVISION SURGERY WAS PERFORMED TO TAKE OUT THE BROKEN HARDWARE WHICH WAS JUST ONE BROKEN SCREW.  THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650223 ↗
• MalfunctionJan 23, 2024Mechanical Problem; Product Quality Problem; Mechanical Problem; Product Quality Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR AN INDICATION OF DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT THE SET SCREW WOULD NOT START IN THE TULIP HEAD. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18561380 ↗
• InjuryMar 20, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL SURGERY FOR THE TREATMENT OF LYTIC SPONDYLOLISTHESIS (L5-S1) AND BACK PAIN. AT THE SURGERY, THE DOCTOR INSERTED SCREWS IN ORDER TO CORRECT THE AFFECTED DISK. THE SCREW USED DURING THE PROCEDURE WAS TITANIUM IMPLANT SCREWS. POST-OPERATIVELY, ON AN UNKNOWN DATE, THE PATIENT DISCOVERED THAT THE TITANIUM SCREWS INSTALLED IN HER LOWER BACK BROKE IN HALF. REPORTEDLY, THE PATIENT SUFFERED SEVERE PAIN AND LACK OF MOBILITY THAT LIMITED HER EVERYDAY ACTIVITIES. ON AN UNKNOWN DATE, REVISION SURGERY WAS PERFORMED IN ORDER TO REMOVE THE SCREWS AND PREVENT FURTHER DAMAGE TO HER SPINE. ON (B)(6) 2014: PRE-OP DIAGNOSIS: L5 BILATERAL SPONDYLOLYSIS. BACK PAIN. GRADE II SPONDYLOLISTHESIS OF L5-S1. PROCEDURES: BILATERAL SEGMENTAL INSTRUMENTATION FROM L5 THROUGH SACRUM. POSTERIOR SPINAL FUSION, L5 THROUGH SACRUM. HARVESTING OF ILIAC CREST BONE GRAFT THROUGH A SEPARATE INCISION. USE OF ILIAC CREST BONE GRAFT AND FRESH FROZEN ALLOGRAFT BONE FOR FUSION. AS PER OP-NOTES: LONGITUDINAL INCISION WAS MADE DISSECTING DOWN BETWEEN L5 AND S1. AT L5 6.5MM DIAMETER X 55 MM LENGTH SCREWS WERE FOUND TO BE FITTING. AT S1 6.5MM DIAMETER X 50 MM LENGTH SCREWS WERE FOUND

  Patient problems: Ambulation or Postural Difficulties; Neuropathy; Pain; Tingling; Weakness

  MAUDE report 7351984 ↗

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.