CD HORIZON® Spinal System 55410006540Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169074002), received between Aug 31, 2017 and Aug 31, 2017 — 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 31, 2017Break; Break

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: REVISION SURGERY (L2-S1) BECAUSE OF THE BROKEN SCREWS IN S1 LEVELS IMPLANTED: S1 IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FROM L2-S1 WITH FIXED ANGLE SCREWS. POST-OP, S1 SCREW WAS BROKEN AND REVISION SURGERY WAS PERFORMED TO REMOVE THE SCREW. THE DISTAL HALF OF THE SCREW REMAINED IN THE PATIENT. IT WAS REPORTED THAT PATIENT HAD CONSTRUCTION FAILURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6833454 ↗
• InjuryAug 31, 2017Break; Break

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: REVISION SURGERY (L2-S1) BECAUSE OF THE BROKEN SCREWS IN S1 LEVELS IMPLANTED: S1 IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FROM L2-S1 WITH FIXED ANGLE SCREWS. POST-OP, S1 SCREW WAS BROKEN AND REVISION SURGERY WAS PERFORMED TO REMOVE THE SCREW.THE DISTAL HALF OF THE SCREW REMAINED IN THE PATIENT. IT WAS REPORTED THAT PATIENT HAD CONSTRUCTION FAILURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6833453 ↗

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.