CD HORIZON® Spinal System 55840006535Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994971739), received between Sep 8, 2017 and May 31, 2025 — classified as 4 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. How this data works · Data updated Oct 13, 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.

• InjuryMay 31, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT ALL THE DEVICES THAT WERE IMPLANTED IN INITIAL SURGERY WERE EXPLANTED BUT ONLY TWO SCREWS THAT WERE ON UPPER LEVEL WERE BROKEN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22120435 ↗
• MalfunctionOct 31, 2023Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SACROILIAC AND THORACOLUMBAR (LOWER/MID SPINE) SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER SNAPPED IN TWO WHILE IMPLANTING SCREW BY HAND, SCREWS SEIZED UP WHEN THE DRIVER BROKE IN IT AND DRIVER SEIZED UP AND WILL NOT RATCHET IN EITHER DIRECTION. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18036492 ↗
• InjuryJan 16, 2023Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION FOR PSEUDARTHROSIS, SCOLIOSIS AND ROD FAILURE. IT WAS REPORTED THAT THE SOLERA MAS SHANK FRACTURED. THE PRODUCT EXPLANTED AND WILL BE RE TURNED. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16173087 ↗
• InjuryApr 20, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SURGERY DUE TO SPONDYLOLISTHESIS AT L5-S1. POST-OP, THE HEAD OF THE LEFT SIDED SCREW WAS FOUND BROKEN. HENCE, THE SCREW THAT WAS IMPLANTED IN (B)(6) 2017 HAD TO BE EXPLANTED IN A REVISION SURGERY IN (B)(6) 2018.

  Patient problems: Discomfort

  MAUDE report 7446020 ↗
• InjurySep 8, 2017Break; Break

  TYPE OF PROCEDURE USED: POSTERIOR LUMBAR SPINAL FUSION LEVELS IMPLANTED: L4 THROUGH S1 IT WAS REPORTED THAT PATIENT UNDERWENT A FOLLOW UP SURGERY ON (B)(6) 2017 TO REVISE CONSTRUCT PLACED ON (B)(6) 2016. REPORTEDLY, ON AN UNKNOWN DATE, POST-OP, SCREW PLACED ON (B)(6) 2017 BROKE AND A REVISION SURGERY WILL BE PERFORMED AT A LATER DATE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT AND BROKE. NO FRAGMENT OF THE IMPLANT REMAINED IN THE PATIENT. PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED UNKNOWN AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6851079 ↗

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.