CD Horizon® Spinal System 55740006040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994997418), received between Oct 7, 2020 and Oct 7, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 7, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF BURST FRACTURE OF L4 INVOLVED IN PLF PROCEDURE USED IN SPINAL THERAPY. LEVELS IMPLANTED: L3-L5. IT WAS REPORTED DURING USE, SCREW SHAFT ON ONE SIDE OF L3 BROKE. ADDITIONAL SURGERY WAS PERFORMED AS A RESULT OF THE EVENT, PSE1 WAS USED AND IMPLANT WAS REMOVED. BONE FUSION WAS ACHIEVED, SO ALL IMPLANT PRODUCTS INCLUDING THE BROKEN SHAFT WERE REMOVED. HENCE, THERE IS NO FRAGMENTS LEFT IN THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE. PATIENT WAS NOT HOSPITALIZED PROLONG. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. PATIENT MEDICAL HISTORY: EPILEPSY PATIENT OUTCOME: NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10643595 ↗