CD HORIZON® Spinal System 55840006540Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00613994971746), received between Dec 28, 2016 and Jul 25, 2025 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2025Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR SCOLIOSIS CORRECTION. LEVELS IMPLANTED WAS RIGHT L2, L3. IT WAS REPORTED THAT A PATIENT UNDERWENT A SCOLIOSIS CORRECTION PROCEDURE WITH A SCREW IMPLANTED AT THE RIGHT L3 PEDICLE. POST-OPERA TIVELY, THE PATIENT COULD FEEL MOVEMENT. INTRAOPERATIVE COMPUTED TOMOGRAPHY SHOWED THE ROD WAS LONG ENOUGH, SETSCREWS WERE IN PLACE, AND SCREWS WERE WITHIN THE PEDICLE. HOWEVER, POST-OPERATIVE COMPUTED TOMOGRAPHY REVEALED THAT THE SETSCREW HAD POPPED OFF THE RIGHT L3 SCREW AND THE RIGHT L3 SCREW HAD MIGRATED INTO THE SUPERIOR ENDPLATE. THE L3 SCREWS WERE REPLACED. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE ARE NO INJURIES, BUT THE PATIENT REQUIRED AN ADDITIONAL OPERATION TO CORRECT WHERE THE SETSCREW CAME OFF THE ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607342 ↗
• InjuryJun 11, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR SCOLIOSIS. IT WAS REPORTED THAT THE SCREWS WERE BROKEN POST OPERATIVELY. SCREWS WERE REPLACED WITH LARGER SIZE AND DIAMETER 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 22181991 ↗
• InjuryMay 31, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT ALL THE DEVICES THAT WERE IMPLANTED IN INITIAL SURGERY WERE EXPLANTED BUT ONLY TWO SCREWS THAT WERE ON UPPER LEVEL WERE BROKEN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22120441 ↗
• InjuryDec 22, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L5-S1 FUSION FOR AN INDICATION OF SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE L5-S1 PEDILE SCREW BROKE POST-OPERATIVELY AND THE PATIENT HAD PAIN FROM THE BROKEN HARDWARE MOVING. THE HARDWARE BROKE BEFORE FUSION COULD OCCUR AND REVISION SURGERY WAS PERFORMED ON 27-NOV-23 FOR REMOVAL OF BROKEN L5-S1 PEDICLE SCREW INSTRUMENTATION WITH REINSERTION OF NEW L5-S1 PEDICLE SCREWS, L5-S1 TRANSFORAMINAL DISCECTOMY AND INTERBODY FUSION WITH INTERBODY FUSION CAGE AND LOCAL AUTOGENOUS MORSELIZED BONE GRAFT AUGMENTED CANCELLOUS ALLOGRAFT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 18382337 ↗
• MalfunctionDec 7, 2023Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WITH CLINICAL ID (B)(4). IT WAS REPORTED THAT CT SHOWED A BROKEN S1 SCREW ON THE RIGHT SIDE. THE PATIENT CURRENTLY HAS NO OBVIOUS SYMPTOMS AND NO INDICATION FOR FURTHER SURGERY THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18281459 ↗
• MalfunctionSep 4, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE STATING IT WAS TWO S1 SCREWS WERE BROKEN. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17675687 ↗
• InjuryJan 20, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR DECOMPRESSION AND FUSION WITH INSTRUMENTATION FOR CONSTRUCT REVISION. LEVELS IMPLANTED: L3-L5 IT WAS REPORTED THAT THE DEVICES BROKE. THE TULIP AND PARTIAL LENGTH OF SCREW SHAFT WAS EXPLANTED BUT THE DISTAL LENGTH OF SCREW REMAINED IN VERTEBRAL BODY. THIS ADDITIONAL SURGERY WAS PERFORMED TO REPLACE IMPLANTS AND EXTEND THE CONSTRUCT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16213065 ↗
• InjuryJan 20, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR DECOMPRESSION AND FUSION WITH INSTRUMENTATION FOR CONSTRUCT REVISION. LEVELS IMPLANTED: L3-L5 IT WAS REPORTED THAT THE DEVICES BROKE. THE TULIP AND PARTIAL LENGTH OF SCREW SHAFT WAS EXPLANTED BUT THE DISTAL LENGTH OF SCREW REMAINED IN VERTEBRAL BODY. THIS ADDITIONAL SURGERY WAS PERFORMED TO REPLACE IMPLANTS AND EXTEND THE CONSTRUCT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16213059 ↗
• InjuryJul 4, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L5-S1 LUMBAR SP INE DEGENERATION SURGERY. IT WAS REPORTED THAT THE TWO SCREWS IN S1 WERE BROKEN AND THE ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2022 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 14903594 ↗
• InjuryDec 28, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PART USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SCREW WAS BROKEN. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED STATES THAT FIRST CASE WITH THIS SCREWS 31.10.2018 L1-3. SECOND CASE (REASON BROKEN SCREWS L3) (B)(6) 2020 WITH REVISION TO L1-S1 (SCREW TIPS LEFT IN PATIENT). PATIENT IS OVERWEIGHT AND SMOKES. PATIENT WAS RELEASED AT (B)(6) 2020 HOME, GOOD HEALING AND NO PAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11075643 ↗
• InjuryMar 6, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SPONDYLOLISTHESIS; AND UNDERWENT LUMBAR FUSION AT L4-S1. ON (B)(6) 2020, POST-OP, THE DOCTOR FOUND THAT AN IMPLANTED S1 SCREW HAD BROKEN. THE PATIENT ALSO EXPERIENCED PAIN. HENCE, A REVISION SURGERY WAS PERFORMED, IN WHICH IT WAS FOUND THAT BOTH S1 SCREWS (ONE AT EITHER SIDE OF S1) HAD FRACTURED. BOTH THE BROKEN SCREWS WERE COMPLETELY EXPLANTED. THE PREVIOUS CONSTRUCT WAS ALSO REVISED DURING THIS SURGERY.

  Patient problems: Pain

  MAUDE report 9803074 ↗
• InjuryMar 6, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SPONDYLOLISTHESIS; AND UNDERWENT LUMBAR FUSION AT L4-S1. ON (B)(6) 2020, POST-OP, THE DOCTOR FOUND THAT AN IMPLANTED S1 SCREW HAD BROKEN. THE PATIENT ALSO EXPERIENCED PAIN. HENCE, A REVISION SURGERY WAS PERFORMED, IN WHICH IT WAS FOUND THAT BOTH S1 SCREWS (ONE AT EITHER SIDE OF S1) HAD FRACTURED. BOTH THE BROKEN SCREWS WERE COMPLETELY EXPLANTED. THE PREVIOUS CONSTRUCT WAS ALSO REVISED DURING THIS SURGERY.

  Patient problems: Pain

  MAUDE report 9803068 ↗
• MalfunctionJun 28, 2017Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGERY DURING WHICH THE SCREW WAS MAL-POSITIONED UPON INSERTION. THIS WAS OBSERVED THROUGH C-ARM IMAGE, AND SUBSEQUENTLY AN O-ARM IMAGE SPIN. FROM ANOTHER C-ARM IMAGE TAKEN POST OPERATIVELY, INFERENCE WAS THAT THE SCREW WAS LOOSE IN THE DRIVER TO THE POINT THAT IT WAS UNABLE TO BE CONTROLLED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6672533 ↗
• InjuryDec 28, 2016Break; Break

  IT WAS REPORTED PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF SPONDYLOLISTHESIS L5-S1 WITH SPONDYLARTHROSIS UNDERWENT AN UNSPECIFIED SPINAL PROCEDURE AT L5-S1. ON AN UNKNOWN DATE, POST-OP, THE SCREW WAS FOUND BROKEN. PATIENT HAD PSEUDOARTHROSIS AND BACK PAIN AS A RESULT OF WHICH THIS PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPLACE THE BROKEN SCREW AND IMPLANT A CAGE. NO FRAGMENTS OF THE BROKEN SCREW REMAINED IN PATIENT. AFTER REVISION SURGERY PATIENT IS FINE.

  Patient problems: No Code Available; Pain

  MAUDE report 6207955 ↗

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.