CD HORIZON® Spinal System X1013202Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169468634), received between Feb 25, 2025 and Feb 25, 2025 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY VIA A MEDTRONIC REPRESENTATIVE REGARDING A SCREW DRIVER USED IN A POSTERIOR FUSION PROCEDURE. IT WAS REPORTED THAT INSTRUMENT WAS BROKEN. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. EVENT DID NOT OCCUR AT BACK TABLE, OCCURRED FROM CONSTANT USAGE. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456312 ↗