CD Horizon® Spinal System 1554300500Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169035973), received between Apr 8, 2024 and Jul 3, 2025 — 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 16, 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.

• InjuryJul 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION THERAPY FOR SPINAL CANAL STENOSIS. LEVELS INVOLVED WAS L5-S1. IT WAS REPORTED THAT THE POSTOPERATIVE JACK DOWN. PATIENT EXPERIENCED BONE FUSION FAILURE AND INSTABILITY, WHICH LED TO REVISION SURGERY. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE IMPLANT POSITION REMAINED INTACT, AND THE OPEN CAGE SHRANK. RE-SURGERY WAS PERFORMED DUE TO INSTABILITY, THE PATIENT HAS RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT INSTABILITY DEVELOPED DUE TO BONE FUSION FAILURE AND ROD BREAKAGE AFTER JACKING DOWN, SO A DIFFERENT CAGE WAS INSERTED AND THE ROD WAS RE-FASTENED FOR RE-SURGERY. THERE WERE NO PATIENT SYMPTOMS DEVELOPED AFTER RE-SURGERY. THERE WERE NO COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT ROD BREAKAGE OCCURRED ON L5-S1.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 22392427 ↗
• InjuryApr 8, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR ROD REPLACEMENT. REVISION SURGERY WAS PERFORMED SURE TO ROD BREAKAGE. PROCEDURE TAKEN WAS T8/S2AI FIXATION, L2 VERTEBRAL BODY REPLACEMENT. IT WAS REPORTED THAT THE END CAP LOCK LOOSENING. WHEN SURGEON CHECKED THE IMAGE WITH THE ROD BREAKAGE, THE ANGLE OF THE END CAP CHANGED COMPARED TO AFTER THE FIRST OPERATION, AND THE ANGLE CHANGED EVEN AFTER THE ROD WAS REPLACED THIS TIME. IT IS CONSIDERED THAT THE LOCK OF THE END CAP IS FREE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057213 ↗
• InjuryApr 8, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAG NOSIS FOR ROD REPLACEMENT. REVISION SURGERY WAS PERFORMED SURE TO ROD BREAKAGE. PROCEDURE TAKEN WAS T8/S2AI FIXATION, L2 VERTEBRAL BODY REPLACEMENT. IT WAS REPORTED THAT THE END CAP LOCK LOOSENING. WHEN SURGEON CHECKED THE IMAGE WITH THE ROD BREAKAGE, THE ANGLE OF THE END CAP CHANGED COMPARED TO AFTER THE FIRST OPERATION, AND THE ANGLE CHANGED EVEN AFTER THE ROD WAS REPLACED THIS TIME. IT IS CONSIDERED THAT THE LOCK OF THE END CAP IS FREE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057210 ↗