CD HORIZON® Spinal System 1554200500Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994990679), received between Feb 1, 2018 and Nov 4, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING AN EVENT WHICH OCCURRED POST A CLINICAL STUDY (STUDY ID: (B)(6)) T10 -L4 POSTERIOR SPINAL FIXATION AND FUSION PROCEDURE IN A PATIENT (PATIENT ID: (B)(6)). IT WAS REPORTED THAT PATIENT HAD WORSENING PAIN IN AND WAS RE-ADMITTED FOR EVALUATION. X RAY DONE ON (B)(6) 2025 DEMONSTRATED SIGNIFICANT DISC HERNIATIONS AT T7/8 AND 8/9 CAUSING SEVERE STENOSIS. THE DECISION WAS MADE TO THE EXTEND THE FUSION TO T4 WITH THORACIC DISCECTOMY FOR DECOMPRESSION. PATIENT WAS RE-HOSPITALIZED ON (B)(6) 2025 TO (B)(6) 2025 AND UNDERWENT ADDITIONAL SURGERY ON (B)(6) 2025 TO REMOVE IMPLANTS AND FUSION WAS EXTENDED DUE TO INTERVERTEBRAL THORACIC DISC DISORDER WITH MYELOPATHY. AS PER SITE ASSESSMENT, EVENT IS POSSIBLY RELATED TO STUDY DEVICE AND CAUSALLY RELATED TO THE PROCEDURE. AS PER SPONSOR ASSESSMENT, EVENT IS PROBABLY RELATED TO THE INDEX SURGERY AND NOT RELATED TO THE DEVICE. NO DEVICE MALFUNCTION REPORTED. THERE WAS NO PATIENT INVOLVEMENT/SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Intervertebral Disc Compression or Protrusion; Pain; Spinal Cord Injury; Stenosis

  MAUDE report 23462170 ↗
• InjuryNov 9, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A PATIENT VIA A MEDTRONIC REPRESENTATIVE REGARDING A ROD POST-SURGERY. IT WAS REPORTED THAT ROD BROKE IN HER BACK ON (B)(6) 2020 AND SHE HAS PAIN. THE NEW SURGERY WILL BE ON (B)(6) 2020. THE DATE OF IMPLANT WAS (B)(6) 2020 AND THE DATE OF EXPLANT WAS (B)(6) 2020. PATIENT IS IN PAIN. HEALTHCARE PROFESSIONAL'S DIAGNOSIS WAS FRACTURE AT THE L5 LEVEL. INITIAL SURGERY IN JUNE WAS FOR SCOLIOSIS, FROM ¿NECK TO TAIL BONE¿. THERE WERE NO ISSUES WITH THE TISSUE PRODUCTS. ON NOVEMBER 11, 2020: NURSE INTERVIEW NOTES ((B)(6), LPN)- PATIENT CAME IN TODAY FOR A PRE-OP PX. SHE STATED THAT SHE HAD A ROD IN HER BACK THAT "SNAPPED" IN HALF. SHE IS CONCERNED BECAUSE SHE IS ON BLOOD THINNERS. SHE IS HAVING A LOT OF BACK PAIN R/T THIS TODAY TOO. SHE NEEDS A REFILL ON HER MEDICATIONS. PROGRESS NOTE- PATIENT PRESENTED TO THE CLINIC TODAY FOR A PREOP HISTORY AND PHYSICAL EXAM. SHE IS HAVING BACK SURGERY DONE TO A REPORTED SURGICAL DEVICE MALFUNCTION IN HER BACK. SHE STATES THAT SHE HAD BACK SURGERY EARLIER THIS SUMMER. SHE CONTINUES TO HAVE ISSUES WITH CHRONIC PAIN SECONDARY TO HER BACK AS WELL AS HER INFLAMMATORY ARTHRITIS. HER MEDICATIONS WERE REVIEWED. NO OTHER RECENT CHANG

  Patient problems: Pain

  MAUDE report 12776850 ↗
• InjuryFeb 1, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT UNSPECIFIED SURGERY AND POST-OP RODS BROKE. AS THE RESULT, THE PATIENT SUFFERED FROM PAIN.A REVISION SURGERY WAS SCHEDULED ON (B)(6) 2018. NON UNION WAS REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7234737 ↗
• InjuryFeb 1, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT UNSPECIFIED SURGERY AND POST-OP RODS BROKE. AS THE RESULT, THE PATIENT SUFFERED FROM PAIN.A REVISION SURGERY WAS SCHEDULED ON (B)(6) 2018. NON UNION WAS REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7234720 ↗
• InjuryFeb 1, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT UNSPECIFIED SURGERY AND POST-OP RODS BROKE. AS THE RESULT, THE PATIENT SUFFERED FROM PAIN.A REVISION SURGERY WAS PERFORMED TO EXPLANT THE ROD. NON UNION WAS REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7234705 ↗
• InjuryFeb 1, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT UNSPECIFIED SURGERY AND POST-OP RODS BROKE. AS THE RESULT, THE PATIENT SUFFERED FROM PAIN.A REVISION SURGERY WAS PERFORMED TO EXPLANT THE ROD. NON UNION WAS REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7234651 ↗

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.