CD HORIZON® Spinal System 1606000500Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994974297), received between Jul 14, 2017 and Jun 22, 2021 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2021Device Damaged by Another Device; Device Damaged by Another Device

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH SPINE STABILIZATION/FUSION FOR THORACOLUMBAR FUSION SPINAL THERAPY. IT WAS REPORTED THAT FROM RIGHT SIDE IMPLANTS THE SET SCREW WAS LOOSE. SADDLE OF THE BALLAST SCREW SEEMED DEFECTIVE WHEN HE USED THE TULIP ALIGNER FOR SCREW REMOVAL. FROM LEFT SIDE IMPLANTS SET SCREW SEEMED TIGHT AND NORMAL. TULIP ANGLE OF BALLAST SCREW SEEMED CHANGED SINCE POST OP STANDING FILMS. THE PATIENT HAD PELVIC FRACTURE SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. REMOVAL OF BALLAST SCREWS, SET SCREWS AND RODS. REPLACED WITH LARGER DIAMETER BALLAST SCREWS, NEW SET SCREWS AND NEW RODS. IT WAS UNSURE IF THE RODS HAD ANY PART OF THE PRODUCT FAILURE. SENT THEM WITH THE SCREWS AND THE SET SCREWS SO ALL AVAILABLE IMPLANTS WERE TOGETHER TO GET TESTED. WE CAN NOT SAY WITH CERTAINTY THE FRACTURE WAS A RESULT OF THE IMPLANTS.

  Patient problems: Bone Fracture(s)

  MAUDE report 12038725 ↗
• MalfunctionJul 20, 2017Break; Break

  PROCEDURE: SCOLIOSIS ADULT LEVELS: S1-ILIAC-T3 IT WAS REPORTED THAT ON (B)(6) 2017, POST-OP, ROD WAS FOUND TO BE BROKEN IN X-RAY IMAGE. PATIENT STATUS WAS REPORTED UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6727371 ↗
• InjuryJul 14, 2017Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  PATIENT CLINICAL ID: LUCUS 1-2-3-4 PRE-OP DIAGNOSIS: DISBALANCE SAGITAL LUMBAR PROCEDURE: SCOLIOSIS DISBALANCE SAGITAL LEVEL: T3-ILLIAC IT WAS REPORTED THAT PATIENT UNDERWENT A SURGERY. POST-OP, PAIN AND INSTABILITY WAS OBSERVED IN THE PATIENT.

  Patient problems: No Code Available; Pain

  MAUDE report 6713265 ↗

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.