CD HORIZON® Spinal System 1553201070Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169015906), received between Mar 31, 2020 and Mar 26, 2025 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THER APY. IT WAS REPORTED THAT THE FDA TAB OF THE DEVICE HAS BROKEN. 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 21697875 ↗
• MalfunctionMar 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THER APY. IT WAS REPORTED THAT THE FDA TAB OF THE DEVICE HAS BROKEN. 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 21697805 ↗
• MalfunctionMar 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THER APY. IT WAS REPORTED THAT THE FDA TAB OF THE DEVICE HAS BROKEN. 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 21697684 ↗
• MalfunctionMar 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THER APY. IT WAS REPORTED THAT THE FDA TAB OF THE DEVICE HAS BROKEN. 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 21697225 ↗
• MalfunctionMar 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THER APY. IT WAS REPORTED THAT THE FDA TAB OF THE DEVICE HAS BROKEN. 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 21697186 ↗
• MalfunctionMar 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THER APY. IT WAS REPORTED THAT THE FDA TAB OF THE DEVICE HAS BROKEN. 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 21696418 ↗
• MalfunctionMar 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THER APY. IT WAS REPORTED THAT THE FDA TAB OF THE DEVICE HAS BROKEN. 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 21696348 ↗
• MalfunctionDec 29, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE FDA TAB OF THE DEVICE HAS BROKEN. 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 21032138 ↗
• InjuryApr 18, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER, REGULATORY BODY VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCTS. IT WAS REPORTED THAT, SPINAL RODS WERE BROKEN AT L4/L5 AND SCREWS WERE LOOSE AT L5/S1. REVISION SURGERY WAS PERFORMED TO EXPLANT THE  BROKEN RODS. LOOSE SCREWS EXPLANTED DURING REVISION SURGERY. NO INFORMATION WAS AVAILABLE ON THE EXPLANT OF LOOSE SCREWS. THERE WERE NO PATIENT SYMPTOMS REPORTED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19132663 ↗
• InjuryJun 30, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED. PROCEDURE OR TECHNIQUE PERFORMED WAS LUMBAR/SACRAL FUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17235868 ↗
• 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 9902749 ↗

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.