CD HORIZON® Spinal System 55840007535Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169004320), received between Jul 18, 2017 and Aug 13, 2019 — 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.

• MalfunctionAug 13, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR DISC DECOMPRESSION, FUSION AND THE PEDICLE SCREW ROD SYSTEM INTERNAL FIXATION SURGERY. ON (B)(6) 2019, POST OP, PATIENT'S RADIOLOGICAL FILMS SHOWED THE PEDICLE SCREW TO BE BROKEN. IT IS UNKNOWN WHEN THE SCREW BROKE AND IF THE PATIENT HAD ANY COMPLICATIONS DUE TO THIS EVENT. NO MORE INFORMATION IS AVAILABLE YET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8889577 ↗
• InjuryAug 3, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT FUSION AT L4-L5 AND L5-S1 DUE TO LUMBAR SPONDYLOLISTHESIS. ON (B)(6) 2019, POST-OP, A RADIOLOGY WAS PERFORMED WHICH SHOWED SCREW BROKEN AT L5-S1. FUSION WAS NOT ACHIEVED AT L5-S1 DUE TO THE BROKEN SCREW. THE BROKEN SCREW IS STILL IMPLANTED INSIDE THE PATIENT; AND THERE IS NO PLAN FOR REVISION SURGERY YET. THE PATIENT WILL BE UNDER OBSERVATION FOR SOME TIME.

  Patient problems: Failure of Implant

  MAUDE report 8858214 ↗
• InjuryJul 18, 2017Break; Break

  IT WAS REPORTED THAT PATIENT ISSUE IS RESOLVED.

  Patient problems: No Code Available; Pain

  MAUDE report 6720591 ↗

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.