CD HORIZON® Spinal System 55740106540Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169052987), received between Mar 6, 2024 and Jun 30, 2026 — 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 16, 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.

• MalfunctionJun 30, 2026Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM CLINICAL STUDY, HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID: (B)(6), AND STUDY ID: TLIF IDE PIVOTAL - (B)(4). IT WAS REPORTED THAT DURING MMI IMAGING ANALYSIS, HARDWARE LOOSENING WAS OBSERVED. PATIENT WAS TREATED FOR 2 LEVELS. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO REVISION SURGERY PLANNED OR SCHEDULED FOR THE REMOVAL OF IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25662299 ↗
• InjuryMar 6, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING L5/S1 PLIF FOR AN INDICATION OF GRADE 1 SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE BILATERAL S1 SCREWS WERE BROKEN AND AN ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2024 TO REMOVE THE BROKEN SCREWS. 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 18843711 ↗
• InjuryMar 6, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING L5/S1 PLIF FOR AN INDICATION OF GRADE 1 SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE BILATERAL S1 SCREWS WERE BROKEN AND AN ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2024 TO REMOVE THE BROKEN SCREWS. 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 18843681 ↗

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.