CD HORIZON® Spinal System 55740106545Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169052970), received between Apr 13, 2018 and Jun 30, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• 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 25662276 ↗
• 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 25662270 ↗
• InjuryJun 30, 2023Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROFESSIONAL, RISK MANAGER, REGULATORY BODY) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH SPINE HARDWARE. IT WAS REPORTED THAT THE LUMBAR SPINE HARDWARE WAS BROKEN. THE PATIENT WAS HOSPITALIZED. SCREW WAS EXPLANTED ON (B)(6) 2022. PATIENT COMPLICATIONS WERE UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17235219 ↗
• InjuryMay 16, 2018Break; Break

  LEVELS IMPLANTED AND PROCEDURE: L3-S1 POSTERIOR LUMBAR FUSION IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE IMPLANTED SCREW ON S1 BROKE DUE TO NON UNION. THE PATIENT UNDERWENT REVISION SURGERY FOR THE EXPLANATATION OF THE BROKEN SCREW. APPROX. 40MM OF SCREW SHAFT IS STILL REMAINING IN THE PATIENT BODY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7517459 ↗
• InjuryApr 13, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT LUMBAR FUSION AT S1. POST -OP, THE SCREW WAS BROKEN AT S1. PATIENT COMPLAINED THAT THE SQUEEKING NOISES IN BACK BEGAN FEW MONTHS AFTER THE INITIAL SURGERY. REVISION SURGERY WAS PERFORMED TO EXPLANT THE BROKEN SCREWS. NO ANY FRAGMENTS WERE REMAINED IN PATIENT IN THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7430001 ↗
• InjuryApr 13, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT LUMBAR FUSION AT S1. POST -OP, THE SCREW WAS BROKEN AT S1. PATIENT COMPLAINED THAT THE SQUEAKING NOISES IN BACK BEGAN FEW MONTHS AFTER THE INITIAL SURGERY. REVISION SURGERY WAS PERFORMED TO EXPLANT THE BROKEN SCREWS. NO ANY FRAGMENTS WERE REMAINED IN PATIENT IN THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7429965 ↗

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.