CD HORIZON® Spinal System 55890006550Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169058170), received between Feb 23, 2021 and Mar 6, 2023 — classified as 1 injury, 1 malfunction.

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 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.

• InjuryMar 6, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH SCREW USED IN TLIF PROCEDURE. IT WAS REPORTED THAT THE IMPLANT WAS BROKEN AFTER INITIAL SURGERY. IT WAS KNOWN 3 MONTHS AFTER THE FIRST SURGERY. ADDITIONAL SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT FOR IMPLANT REVISION. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE FOUND OUT TO BE CENTRAL STENOSIS & ASD. ADVERSE EVENT OR PATIENT SYMPTOMS AS A RESULT OF THIS EVENT IS UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED. ADDITIONAL INFORMATION RECEIVED. IT WAS REPORTED THAT ADDITIONAL SURGERY WAS PERFORMED IN THIS EVENT TO REMOVE PREVIOUS IMPLANT AND IMPLANT THE NEW ONE. IMPLANT WAS FOUND BROKEN IN THE BODY AND THERE ARE MANY SYMPTOMS REGARDING PATIENT¿S DISEASE. ADDITIONAL INFORMATION RECEIVED. IT WAS REPORTED THAT WHEN SCREW WAS BROKEN IN THE BODY, BROKEN PART MADE SOME PAIN AND SOMETIMES IT HURTS MOTOR/SENSORY NERVES.

  Patient problems: Pain

  MAUDE report 16484802 ↗
• MalfunctionFeb 23, 2021Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING POSTERIOR SLIP RESET PROCEDURE IN A PATIENT DIAGNOSED WITH SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE SPACER BROKE, THE SC REWDRIVER'S HOLDING PATTERN WAS DAMAGED AND IT WAS IMPOSSIBLE TO SCREW AND THE SET SCREWS SLIPPED. CAGE WAS PULLED OUT WITH TOOLS ON THE SPOT, NO SECONDARY SURGERY. PRODUCTS WILL BE RETURNED. NO PATIENT INJURY / COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11363848 ↗

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.