CD HORIZON® Spinal System 25630018590Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169412637), received between Jan 30, 2019 and May 6, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

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.

• InjuryMay 6, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SPINAL PRODUCT FOR POSTERIOR SPINAL FUSION. PATIENT HAD A MEDICAL HISTORY OF STENT PLACEMENT, HYPERTENSION, GLAUCOMA. IT WAS REPORTED THAT, THE IMPLANTED SCREW WAS BROKEN. REVISION SURGERY WAS PERFORMED TO EXPLANT THE BROKEN SCREW. THERE WERE NO FRAGMENTS OF THE BROKEN SCREW REMAINED IN PATIENT. PATIENT HAD A SYMPTOM OF PSEUDARTHROSIS. PSEUDARTHROSIS WAS DEVELOPED AT THE IMPLANT LEVEL AND THE SCREW WAS BROKEN AT ONE MONTH BEFORE FUSION OCCURRED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11782995 ↗
• InjuryJan 30, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH FAILED FUSION AND UNDERWENT SCREW PLACEMENT SURGERY AT S2- ILIAC LEVELS. POST-OPERATIVELY, THE SCREWS WERE BROKEN AT THE SHAFTS. AS A RESULT, REVISION SURGERY WAS PERFORMED TO REPLACE THE PRODUCT. THE SCREW SHAFT OF THE BROKEN PRODUCT REMAINED INSIDE THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 8287963 ↗
• InjuryJan 30, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH FAILED FUSION AND UNDERWENT SCREW PLACEMENT SURGERY AT S2- ILIAC LEVELS. POST-OPERATIVELY, THE SCREWS WERE BROKEN AT THE SHAFTS. AS A RESULT, REVISION SURGERY WAS PERFORMED TO REPLACE THE PRODUCT. THE SCREW SHAFT OF THE BROKEN PRODUCT REMAINED INSIDE THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 8287956 ↗