CD Horizon® Spinal System 55740006550Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994995162), received between Aug 16, 2022 and Sep 8, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO PREVIOUSLY HAD L3/4/5 POSTERIOR LUMBAR INTERBODY FUSION (PLIF). POST INITIAL SURGERY PATIENT HAD LOWER EXTREMITY PAIN DUE TO L5/S ADJACENT INTERVERTEBRAL DISORDER AND CONCURRENT DIFFUSE IDIOPATHIC SKELETAL HYPEROSTOSIS (DISH), FIXATION FROM T12 TO THE ILIUM WAS PERFORMED DURING CURRENT SURGERY. IT WAS REPORTED THAT DURING THE PLACEMENT OF THE RIGHT ROD, BENDING WAS INSUFFICIENT; WHILE APPLYING FORCE WITH THE ARI, AN ATTEMPT WAS MADE TO INSERT THE SET SCREW, BUT IT COULD NOT BE PLACED. A ROD REDUCER WAS ALSO USED, BUT THE SET SCREW COULD NOT BE INSERTED PROPERLY; UPON CHECKING THE SCREW HEAD, DEFORMATION WAS FOUND, SO IT WAS REPLACED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993462 ↗
• InjuryAug 16, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW IN A STABILIZATION FOR A PSEUDOARTHROSIS AT L4/L5. IT WAS REPORTED THAT THE SCREW BROKE AND WAS EXPLANTED. PART OF THE SCREW THREAD IS REMAINING IN PATIENT. THERE WAS NO PATIENT INJURY. THERE WAS A SECOND REVISION DUE TO THE BROKEN SCREW. THERE WAS NO TRAUMA AND THE PATIENT HAS BEEN IN THE HOSPITAL AND HAS DONE NO HEAVY LIFTING OR SPORTS. THE DATE OF IMPLANT WAS (B)(6) 2022 AND THE DATE OF EXPLANT WAS (B)(6) 2022. THE PATIENT'S MEDICAL HISTORY INCLUDES DIABETES AND RENAL DEFICIENCY. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15231485 ↗