CD HORIZON® Spinal System 55840009580Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169005341), received between Apr 24, 2017 and Feb 2, 2026 — classified as 2 injuries, 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K113174); they may or may not involve this specific model.

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.

• MalfunctionFeb 2, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ROD REDUCTION DURING INSTRUMENTED SPINAL FUSION PROCEDURE AT T5-PELVIS FOR SCOLIOSIS. IT WAS REPORTED THAT THE HEAD OF THE SCREW HAS POPPED OFF THE SCREW SHAFT AT THE S2 LEVEL. THE SHAFT OF THE SCREW WAS SUCCESSFULLY REMOVED AND THE SCREW WAS REPLACED. THE EVENT OCCURRED INTRAOPERATIVELY, AND NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL TREATMENT OR SURGERY WAS PERFORMED. THE PRODUCT WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24231616 ↗
• InjuryMay 19, 2017Break; Break

  LEVELS IMPLANTED: T2-ILIAC CREST PRE-OP DIAGNOSIS. BROKEN SCREW AND RODS PROCEDURE: REMOVE BROKEN SCREW (TULIP HEAD ONLY) AND REPLACE BROKEN RODS IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE PATIENT UNDERWENT A SURGERY FOR REMOVAL OF A BROKEN SCREW. THE SCREW WAS REMOVED PARTIALLY.

  Patient problems: No Code Available

  MAUDE report 6577663 ↗
• InjuryApr 24, 2017Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE SCREW BROKE WHICH WAS DETECTED THROUGH X-RAY. HENCE, A REVISION SURGERY WAS PERFORMED TO EXPLANT THE SCREW.

  Patient problems: No Code Available

  MAUDE report 6515090 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113174. One submission often covers many models, so check the product and lot details in each record.

• Z-2603-2018 · Jul 9, 2018 · Terminated
  Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.