CD HORIZON® Spinal System 55840016550Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169077294), received between Dec 22, 2017 and May 14, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionMay 14, 2021Failure to Align; Mechanical Jam; Failure to Align; Mechanical Jam

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH A PRE-OPERATIVE DIAGNOSIS OF METAL EXPLANT. IT WAS REPORTED THAT WHEN SURGEON TRIED TO EXPLANT THE SCREW, BUT IT WAS VERY DIFFICULT BECAUSE IT SEEMS "COLD WELDED", AND IT WAS NEARLY IMPOSSIBLE TO INSERT THE SCREW DRIVER INTO THE SCREW HEAD. PRODUCT IS EXPLANTED. THERE WERE NO  PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE FRACTURE HAD HEALED AND WAS STABLE, THE PATIENT WANTED THE METAL TO BE TO REMOVED. THE SCREWHEAD WAS BLOCKED BY THE PLATE PARTIALLY AND STUCK. THERE WAS DELAY OF ABOUT 25 - 30 MIN IN OVERALL PROCEDURE TIME, ADDITIONAL TOOLS/ SCREWDRIVER WERE NEEDED TO REMOVE THE SCREW. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11824667 ↗
• MalfunctionDec 22, 2017Break; Break

  IT WAS REPORTED THAT INTRA-OP, WHEN THE SURGEON WANTED TO GO DEEPER INTO THE PEDICLE WITH THE IMPLANT, THE SCREW HEAD OF THE IMPLANT CAME LOOSE FROM THE REST OF THE SCREW. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THE PRODUCT BROKE. NO FRAGMENT OF THE IMPLANT REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7141539 ↗

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.