CD Horizon™ Astute™ Spinal System 1608451030Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000312923), received between Apr 25, 2025 and Feb 26, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN A POSTERIOR LUM BAR INTERBODY FUSION (PLIF) PROCEDURE AT LEVELS L4-S1. IT WAS REPORTED THAT BOTH PEEK RODS WERE FOUND TO BE FRACTURED IN THE PATIENT; THIS WAS NOT DIAGNOSED RADIOGRAPHICALLY AND WAS ONLY DISCOVERED DURING SURGICAL EXPOSURE. THE ROD BREAKAGE LIKELY CONTRIBUTED TO A DJACENT SEGMENT DEGENERATION, NECESSITATING A PLIF EXTENSION. THERE WERE NO PATIENT SYMPTOMS REPORTED, AND NO FURTHER COMPLICATIONS WERE NOTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24450975 ↗
• InjuryFeb 9, 2026Break

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE. LEVELS IMPLANTED: L4-5 IT WAS REPORTED THAT DURING ORIGINAL FUSION RODS WERE FOUND TO BE BROKEN. THE BROKEN RODS WERE EXPLANTED. 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 24288863 ↗
• InjuryFeb 9, 2026Break

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE. LEVELS IMPLANTED: L4-5 IT WAS REPORTED THAT DURING ORIGINAL FUSION RODS WERE FOUND TO BE BROKEN. THE BROKEN RODS WERE EXPLANTED. 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 24288849 ↗
• InjuryApr 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A PATIENT HAVING PLIF EXTENSION L3/4 FOR ADJACENT SEGMENT DEGENERATION AT L3/4. IT WAS REPORTED THAT DURING A PLIF EXTENSION PROCEDURE IMPLANT EXPERIENCED BREAKAGE. IT WAS CONFIRMED THAT NO FRAGMENT OF THE IMPLANT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS OR SYMPTOMS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; Spinal Column Injury

  MAUDE report 21906691 ↗