CD HORIZON® Spinal System 1553201080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169015883), received between Mar 31, 2020 and Jan 7, 2025 — classified as 3 injuries.

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

• InjuryJan 7, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH RODS HAVING L3, S1 FREE HANDS TECHNIQUE FOR OPEN SURGERY WITH SOLERA SCREW FENESTRATED FOR STENOSIS LUMBAR WITH OSTEOPOROSIS. IT WAS REPORTED THAT RODS WERE BROKEN. REVISION SURGERY WAS PERFORMED TO PLACE NEW RODS. THERE WAS NO PATIENT SYMPTOMS REPORTED. PATIENT HAD RECOVERED FROM THE AILMENTS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093219 ↗
• InjuryJan 7, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH RODS HAVING L3, S1 FREE HANDS TECHNIQUE FOR OPEN SURGERY WITH SOLERA SCREW FENESTRATED FOR STENOSIS LUMBAR WITH OSTEOPOROSIS. IT WAS REPORTED THAT RODS WERE BROKEN. REVISION SURGERY WAS PERFORMED TO PLACE NEW RODS. THERE WAS NO PATIENT SYMPTOMS REPORTED. PATIENT HAD RECOVERED FROM THE AILMENTS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093209 ↗
• InjuryMar 31, 2020Break; Break

  IT WAS REPORTED THAT ON: (B)(6) 2018: THE PATIENT UNDERWENT A SPINAL FUSION. IN (B)(6) 2019: THE PATIENT UNDERWENT X-RAY/MRI, WHICH SHOWED THE RODS ON BOTH SIDES TO HAVE BROKEN. HENCE, THE PATIENT WAS SCHEDULED FOR ROD REMOVAL IN (B)(6) 2020. ON (B)(6) 2020: THE PATIENT PRESENTED WITH THE PRE-OPERATIVE DIAGNOSES OF BROKEN RODS AND PSEUDOARTHROSIS. SHE UNDERWENT POSTERIOR LUMBAR FUSION WITH TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L3-S1. THE BROKEN RODS WERE RETURNED TO THE PATIENT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 9902760 ↗

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.