CD HORIZON® Spinal System 1555501040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169081222), received between Apr 22, 2019 and May 21, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2019Break; Break

  THE PATIENT WAS PRE-OPERATIVELY DIAGNOSIS WITH LYTHESIS AND UNDERWENT OPEN FUSION AT L3/4. POST-OP, THE IMPLANTED ROD BROKE. PATIENT UNDERWENT REVISION SURGERY AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8626842 ↗
• InjuryApr 22, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL FUSION SURGERY DUE TO LYTHESIS. POST-OP, THE IMPLANTED ROD BROKE. PATIENT UNDERWENT REVISION SURGERY FOR THE REMOVAL OF BROKEN ROD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8535241 ↗

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.