CD HORIZON® Spinal System 55740106550Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169052963), received between Oct 26, 2022 and Aug 5, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE L2-S1 POSTERIOR SPINAL FUSION WITH TLIF SPACERS AT L3/4, L4/5 AND L5-S1. IT WAS REPORTED THAT AT THE 3 MONTHS POST-OP VISIT, THE SURGEON OBSERVED SCREW FRACTURE AT THE S1 SCREWS, BILATERALLY. FOR THE REVISION SURGERY -- THE SURGEON EXPOSED THE PREVIOUS HARDWARE, REMOVED THE SET SCREWS AND PREVIOUS RODS AND CROSSLINK. HE THEN REMOVED THE BROKEN TULIP HEADS, THEN LEFT THE REMAINING SCREW SHANK IN S1. THE SURGEON THEN PLACED BILATERAL ILIAC SCREWS AND PLACED A NEW ROD AND SET SCREWS. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22713139 ↗
• InjuryAug 5, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE L2-S1 POSTERIOR SPINAL FUSION WITH TLIF SPACERS AT L3/4, L4/5 AND L5-S1. IT WAS REPORTED THAT AT THE 3 MONTHS POST-OP VISIT, THE SURGEON OBSERVED SCREW FRACTURE AT THE S1 SCREWS, BILATERALLY. FOR THE REVISION SURGERY. THE SURGEON EXPOSED THE PREVIOUS HARDWARE, REMOVED THE SET SCREWS AND PREVIOUS RODS AND CROSSLINK. HE THEN REMOVED THE BROKEN TULIP HEADS, THEN LEFT THE REMAINING SCREW SHANK IN S1. THE SURGEON THEN PLACED BILATERAL ILIAC SCREWS AND PLACED A NEW ROD AND SET SCREWS. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22713122 ↗
• InjuryJul 3, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD HARDWARE EXPLANT. IT WAS REPORTED THAT SCREW WAS BROKEN. SCREW WAS LATER EXPLANTED.  THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17245773 ↗
• InjuryJun 30, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A (HEALTHCARE PROFESSIONAL, RISK MANAGER) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH LUMBER SPINE SCREWS. IT WAS REPORTED THAT THE SCREWS WERE BROKEN. THE PATIENT WAS HOSPITALIZED. SCREWS WERE EXPLANTED ON (B)(6) 2022. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17236095 ↗
• InjuryOct 26, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SCREW USED IN NAVIGATED FUSION. LEVELS IMPLANTED: L4 - S1. IT WAS REPORTED THAT THE PATIENT FELL FROM THE TOILET ONTO THE BATHROOM FLOOR AND THE SCREW BROKE MIDWAY AT SHAFT. PART OF IT IS STILL IN THE BONE. A REVISION L4-S1 WAS PERFORMED. PATIENT MEDICAL HISTORY INCLUDES ASTHMA, OBESITY, CHRONIC KIDNEY DISEASE, HYPERTENSION, GERD, AUTO IMMUNE DISEASE, IMMUNOSUPPRESSIVE, DEGENERATIVE JOINT DISEASE (LUMBAR), LEG WEAKNESS, AND HISTORY OF SYSTEMIC LUPUS ERYTHEMATOSUS. PATIENT SYMPTOMS ARE UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15672318 ↗

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.