CD HORIZON® Spinal System 55840018500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169075740), received between Dec 28, 2017 and Aug 27, 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 18, 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.

• InjuryAug 27, 2019Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE IN 2017, THE PATIENT UNDERWENT L4-ILIUM FUSION. ON AN UNKNOWN DATE, POST-OP, THE SCREW BROKE. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH THE BROKEN SCREW WAS EXPLANTED. NO FRAGMENT OF THE BROKEN SCREW REMAINED INSIDE THE PATIENT. THE PATIENT HAD ACHIEVED SOLID FUSION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8936200 ↗
• InjuryDec 28, 2017Break; Break

  IT WAS REPORTED THAT PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH NON UNION AT L5/S1 AND L4/L5 AND UNDERWENT POSTERIOR SPINAL FUSION. POST OP, SCREW WAS BROKEN. PAIN AND NON-UNION WERE REPORTED AS A RESULT OF THE EVENT. A REVISION SURGERY WAS PERFORMED TO EXPLANT THE SCREW. NO FRAGMENTS REMAINED INSIDE THE PATIENT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7150485 ↗

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.