CD HORIZON® Spinal System 55840016545Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169077423), received between Sep 27, 2017 and Mar 2, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Nonstandard Device; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN A TRANSPEDICULAR LUMBAR INSTRUMENTATION PROCEDURE (THREE LEVELS IMPLANTED). IT WAS OBSERVED ON THE BACK TABLE THAT ONE TULIP DID NOT HAVE INTERNAL THREADS, PREVENTING THE SCREWDRIVER FROM ENGAGING OR HOLDING WITHIN THE TULIP. IMPORTANTLY, THERE WAS NO PATIENT INVOLVEMENT OR IMPACT, AND NO FURTHER COMPLICATIONS WERE REPORTED. THE SCREWDRIVER FUNCTIONED PROPERLY WITH ALL OTHER THREADED SCREWS, CONFIRMING THAT THE ISSUE WAS ISOLATED TO THE TULIP, WHICH WAS FOUND TO LACK INTERNAL THREADS AND THUS WAS NOT DUE TO A DEVICE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480203 ↗
• InjuryJan 13, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT REVISION SURGERY WAS PERFORMED AND SCREWS WERE EXPLANTED. THE TWO TIPS OF THE SCREWS AND THE CAGE STAY IN PLACE.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 21137728 ↗
• InjuryJan 13, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT PERCUTAN EOUS STABILIZATION WITH TLIF CAGE SPINAL PROCEDURE FOR SPONDYLOLISTHESIS L4/5, DISCUSPROLAPS AT L4/5 RIGHT. LEVELS IMPLANTED 1. IT WAS REPORTED THAT THE CAGE COLLAPSED AFTER IMPLANTATION AND SCREW WAS BROKEN. THERE WAS A PIECE OF SCREW THREAD LEFT INSIDE THE PATIENT AND PATIENT HAD PAIN DUE TO BROKEN SCREWS. THERE IS A PLAN OF REVISION SURGERY AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 21137643 ↗
• InjuryFeb 26, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT MIS SCREW INSTERTION PROCEDURE AT L5-S1 DUE TO DEGENERATIVE DISC DISEASE. POST-OP, THE SCREW BROKE IN HALF. DUE TO THE SCREW BREAKAGE, THE PATIENT NEEDED REVISION SURGERY LESS THAN 12 MONTH SINCE IMPLANTATION. THE TULIP HEAD AND SOME PART OF THE SCREW (IMPLANTED AT S1 LEVEL) HAVE BEEN REMOVED FROM THE PATIENT, THE REMAINING SCREW HAS BEEN LEFT IN SITU. DUE TO THE FACT PART OF THE SCREW REMAINS IN THE PATIENT IT WAS IMPOSSIBLE TO REPLACE LIKE FOR LIKE AND THEREFORE THE CONSTRUCT NEEDED TO BE EXTENDED - ALL SCREWS FROM THE FIRST OPERATION WERE REMOVED AND REPLACED WITH FENESTRATED SCREWS. THE CONSTRUCT EXTENSION WAS REQUIRED SINCE THE IMPLANTS WERE NOT COMPLETELY FUSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8369146 ↗
• InjurySep 27, 2017Break; Break

  PRE-OP DIAGNOSIS: SPONDYLOLISTHESIS L4/5 GRADE I MEYERDING PROCEDURE: SPONDYLODESE L4/5 360 DEGREES LEVELS IMPLANTED: L4/5 IT WAS REPORTED THAT POST-OP, THE IMPLANTED SCREW BROKE. A REVISION SURGERY WAS PERFORMED TO REMOVE THE BROKEN SCREW. NO PATIENT COM PLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6896761 ↗

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.