CD HORIZON® Spinal System 55740107550Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169052109), received between Jun 30, 2023 and Mar 16, 2026 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Adverse 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)) L5-S1 INTERBODY FUSION PROCEDURE IN A PATIENT (PATIENT ID: (B)(6)). PATIENT MEDICAL HISTORY: CHOLESTEROL, HIGH BLOOD PRESSURE, THROAT CANCER AND GERD INTERVENTIONS: PATIENT WAS HOSPITALIZED FROM (B)(6) 2025 TO (B)(6) 2025 FOR REVISION SURGERY FROM T3 TO PELVIS LEVELS IT WAS REPORTED THAT THE PATIENT HAD: 1: EXPLORATION OF SPINAL FUSION, 2: REVISION POSTERIOR LATERAL SPINAL FUSION T3-S1, 3: T10-L3 POSTERIOR COLUMN OSTEOTOMY, 4: REINSERTION OF SPINAL FIXATION DEVICE (LUMBAR SCREWS), 5: POSTERIOR SEGMENTAL SPINAL INSTRUMENTATION T3- ILIUM, 6: PLACEMENT OF AUTOGRAFT AND ALLOGRAFT FOR SPINAL ARTHRODESIS, 7: T12-L1 INTERBODY FUSION, 8: PLACEMENT OF BIOMECHANICAL DEVICE (TLIF CAGE), 9: OPEN BILATERAL SACROILIAC JOINT ARTHRODESIS AND 10: INTERSPINOUS TETHERING FOR PJF/PJK PROPHYLAXIS. THE AE IS DETERMINED TO BE RESOLVED SUBJECT WAS STABILIZED, RECOVERED, AND DISCHARGED FROM THE HOSPITAL. NO PRODUCT MALFUNCTION. AS PER SITE ASSESSMENT, EVENT IS POSSIBLY RELATED TO STUDY DEVICE AND STUDY PROCEDURE. SPONSOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604149 ↗
• InjuryJan 13, 2025Malposition of Device; Malposition of Device

  INFORMATION WAS RECEIVED FROM CLINICAL STUDY, HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID (B)(4) AND STUDY ID (B)(6). IT WAS REPORTED THAT, FOLLOWING DECOMPRESSION, A REVISION WAS COMPLETED ON THE LEFT L5 SCREW DUE TO A MEDIAL VIOLATION. THE SCREW WAS REMOVED FOR REPOSITIONING AND REPLACEMENT TO A SMALLER SIZE. DUE TO THE INITIAL MEDIAL VIOLATION OF THE FIRST SCREW, THERE WAS A SMALL DUROTOMY ON THE LATERAL ASPECT OF THE THECAL SAC WITHIN THE AXIAL OF THE L5 NERVE ROOT WITH INTACT ARACHNOID SPACE UNDERLYING DUE TO THE ARACHNOID SPACE BEING INTACT, NO LEAKAGE OF CEREBROSPINAL FLUID, AND THE LATERAL LOCATION PRIMARY REPAIR WAS DEEMED EXCEEDINGLY RISKY. DUROTOMY WAS SEALED WITH WATERTIGHT LAYER OF DURA-SEAL DURING CLOSURE. NO CEREBROSPINAL FLUID LEAKAGE NOTED. SCREW REPLACEMENT WAS ALSO CHECKED WITH X-RAYS INTRAOPERATIVELY AND POST OPERATIVELY. SITE SERIOUSNESS ASSESSMENT: SEVERITY OF ADVERSE EVENT WAS MILD. SITE RELATED ASSESSMENT: ADDITIONAL SURGERY AND "OTHER" ASSESSMENT WAS NOT RELATED TO CAPSTONE PEEK SPINAL SYSTEM IMPLANT, TLIF GRAFTING MATERIAL, AND PROCEDURE. CAUSAL RELATIONSHIP TO POSTERIOR SUPPLEMENTAL FIXATION SYSTEM. SPONSOR ASS

  Patient problems: Spinal Cord Injury

  MAUDE report 21135388 ↗
• InjuryAug 7, 2023Break; Break

  INFORMATION WAS RECEIVED FROM VARIOUS SOURCES (HEALTH CARE PROFESSIONAL, RISK MANAGER, REGULATORY BODY) VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH ROD SCREW. IT WAS REPORTED THAT BOTH IMPLANTS WERE BROKEN CAUSING A SCHEDULED RETURN TO THE OPERATING ROOM FOR REMOVAL OF HARDWARE. THE ROD WAS IMPLANTED ON (B)(6) 2021 AND EXPLANTED ON (B)(6) 2023. PATIENT COMPLICATIONS WERE UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17468684 ↗
• 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 17235229 ↗

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.