CD HORIZON® Spinal System 55840007540Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169004337), received between Jul 29, 2022 and Aug 20, 2025 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 18, 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.

• MalfunctionAug 20, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THERE WAS LOOSE INTERNAL FIXATION. THIS WAS SUSPECTED TO BE CAUSED BY LOW-VIRULENCE INFECTION. ONSET DATE 2025-03-25. ADVERSE EVENT (AE): THE AE DID NOT RESULT IN HOSPITALIZATION. HOSPITALIZATION DETAILS: IF THE SUBJECT WAS HOSPITALIZED, IT WAS NOT A PROLONGATION OF AN EXISTING HOSPITALIZATION (>24 HOURS). TREATMENT: THE AE DID RESULT IN TREATMENT. TREATMENT TYPE: THE TREATMENT INVOLVED DRUG THERAPY. OUTCOME STATUS: THE SUBJECT HAS NOT RECOVERED/NOT RESOLVED FROM THE ADVERSE EVENT. DIAGNOSTICS: BLOOD TEST 2 PERFORMED ON 2025-04-03. MRI WITH CONTRAST 1 PERFORMED ON 2025-04-03. DIAGNOSTIC TESTS WERE PERFORMED (ACTION RESULT: YES). ADVERSE EVENT DETAILS: THE ADVERSE EVENT INVOLVES A LUMBOSACRAL SPINAL LEVEL (YES). LEVELS INVOLVED: L3-L4. SUBEVENT NUMBER: 0. NARRATIVE: TWO YEARS AFTER THE OPERATION, A CT RE-EXAMINATION REVEALED: LOOSE INTERNAL FIXATION AT L4 AND S1. BONE DESTRUCTION IN THE L5-S1 INTERVERTEBRAL SPACE. A LARGE NUMBER OF OSTEOPHYTE FORMATIONS IN FRONT OF THE AFFECTED AREA SITE SERIOUSNESS ASSESSME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22846920 ↗
• MalfunctionAug 20, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THERE WAS LOOSE INTERNAL FIXATION. THIS WAS SUSPECTED TO BE CAUSED BY LOW-VIRULENCE INFECTION. ONSET DATE ON (B)(6) 2025. ADVERSE EVENT (AE): THE AE DID NOT RESULT IN HOSPITALIZATION. HOSPITALIZATION DETAILS: IF THE SUBJECT WAS HOSPITALIZED, IT WAS NOT A PROLONGATION OF AN EXISTING HOSPITALIZATION (>24 HOURS). TREATMENT: THE AE DID RESULT IN TREATMENT. TREATMENT TYPE: THE TREATMENT INVOLVED DRUG THERAPY. OUTCOME STATUS: THE SUBJECT HAS NOT RECOVERED/NOT RESOLVED FROM THE ADVERSE EVENT. DIAGNOSTICS: BLOOD TEST 2 PERFORMED ON (B)(6) 2025. MRI WITH CONTRAST 1 PERFORMED ON (B)(6) 2025. DIAGNOSTIC TESTS WERE PERFORMED (ACTION RESULT: YES). ADVERSE EVENT DETAILS: THE ADVERSE EVENT INVOLVES A LUMBOSACRAL SPINAL LEVEL (YES). LEVELS INVOLVED: L3-L4. SUBEVENT NUMBER: 0. NARRATIVE: TWO YEARS AFTER THE OPERATION, A CT RE-EXAMINATION REVEALED: LOOSE INTERNAL FIXATION AT L4 AND S1. BONE DESTRUCTION IN THE L5-S1 INTERVERTEBRAL SPACE. A LARGE NUMBER OF OSTEOPHYTE FORMATIONS IN FRONT OF THE AFFECTED AREA SITE SERIOUSNESS AS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22846891 ↗
• InjuryJan 6, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3-S1 SPINAL FU SION. IT WAS REPORTED THAT THE SET SCREWS POPPED OFF POST-OPERATIVELY AND PATIENT DEVELOPED BACK <(>&<)> LEG PAIN AS A RESULT OF THE EVENT. THE PATIENT HAD INITIAL SURGERY ON (B)(6) 2022 AND REVISION SURGERY WAS PERFORMED AS A RESULT OF THE EVENT ON 2024-SEP-20 TO REPLACE THE HARDWARE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 21077366 ↗
• InjuryJan 6, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3-S1 SPINAL FU SION. IT WAS REPORTED THAT THE SET SCREWS POPPED OFF POST-OPERATIVELY AND PATIENT DEVELOPED BACK LEG PAIN AS A RESULT OF THE EVENT. THE PATIENT HAD INITIAL SURGERY ON (B)(6)2022 AND REVISION SURGERY WAS PERFORMED AS A RESULT OF THE EVENT ON (B)(6) 2024 TO REPLACE THE HARDWARE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 21077358 ↗
• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE STATING THE TARGET LEVELS WERE L4/L5 AND L5/S1. INVESTIGATOR ASSESSMENT STATES, THE ADVERSE EVENT WAS RELATED TO PROCEDURE/DEVICE. POSSIBLE RELATED TO PROCEDURE, POSTERIOR LUMBAR FUSION GRAFTING MATERIAL, POSTERIOR FIXATION AND INTERBODY FUSION. SPONSOR ASSESSMENT STATES, POSSIBLY RELATED TO POSTERIOR LUMBAR FUSION GRAFTING MATERIAL, POSTERIOR FIXATION, INTERBODY FUSION AND NOT RELATED TO SURGICAL FUSION. SPONSOR ASSESSMENT (OC MUO): CEC ASSESSMENT - CAUSAL RELATED TO THE PROCEDURE. POSSIBLE RELATIONSHIP TO POSTERIOR LUMBAR FUSION GRAFTING, POSTERIOR FIXATION AND INTERBODY FUSION. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21046325 ↗
• InjuryAug 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, POST PROCEDURE HARDWARE FAILURE WAS IDENTIFIED ON THE ANTERIOR COLUMN OF SPINE. ACUTE RIGHT LOWER EXTREMITY PAIN THAT STARTS IN THE ANKLE AND RADIATES UP INTO LEG. REPORTS DIFFICULTY AMBULATING. COMPUTED TOMOGRAPHY PERFORMED ON 8 JULY FOUND FRACTURE OF SUPERIOR S1 VERTEBRAL BODY, NONDISPLACED SACRAL ALAR FRACTURE INVOLVING LEFT S1 SCREW, PERIPROSTHETIC LUCENCY SURROUNDING RIGHT S1 SCREW COULD RELATE TO LOOSENING, ANTEROLISTHESIS OF L5 ON S1 ~ 8MM. NONSPECIFIC FLUID WITHIN THE POSTERIOR PARASPINAL SOFT TISSUES. REPORTED ADVERSE EVENT WAS POSSIBLY RELATED TO STUDY PROCEDURE (INDEX SURGERY) POSSIBLY RELATED TO STUDY DEVICE. ADVERSE EVENT RESULTED IN USAGE OF CONCOMITANT MEDICATION. ADDITIONAL SURGERY. PATIENT WAS HOSPITALIZED FROM (B)(6) 2024. ADDITIONALLY, PHYSICAL THERAPY AND DIAGNOSTIC TESTS WERE PERFORMED. ADDITIONAL SURGERY WAS PERFORMED WAS (B)(6) 2024. OUTCOME OF ADVERSE EVENT WAS RECOVERING/RESOLVING. ADDITIONALLY DOPPLER DIAGNOSTIC TEST WAS PERFORMED ON (B)(6) 2024. DUPLEX TEST RESULTS SHOW NEGATIVE

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Pain; Seroma

  MAUDE report 20074276 ↗
• MalfunctionFeb 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED THAT THE LOOSENING OF THE IMPLANT WAS CAUSED BY THE FALL AND NOT BECAUSE OF A PRODUCT. WHILE THIS DOSE INVOLVED THE SURGICAL SCREWS, BUT THE CAUSE OF THE AE WAS THE FALL. INVESTIGATOR¿S ASSESSMENT OF NOT RELATED TO SURGICAL CONSTRUCT AND/OR STUDY PROCEDURE. ALSO, THE SPONSOR HAS UPDATED ASSESSMENT TO NOT RELATED TO CONSTRUCT/STUDY PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695412 ↗
• MalfunctionFeb 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING AN EVENT. IT WAS REPORTED THAT THE S1 SCREW WAS LOOSE. 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 18674221 ↗
• InjuryFeb 5, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A COMPETENT AUTHORITY, HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH REMOVAL OF PREVIOUS HARDWARE. L4-S1 PLIF AT L4/5 AND TLIF AT L5/S1 . IT WAS REPORTED THAT THE BILATERAL BROKEN S1 SCREWS. SCREW WAS EXPLANTED. IT WAS UNKNOWN THAT PATIENT HAD DEVELOPED ANY SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18638493 ↗
• MalfunctionApr 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A REVISION OF LUMBAR DECOMPRESSION AND FUSION PROCEDURE AT L2-PELVIS FOR A PATIENT DIAGNOSED WITH SPINAL STENOSIS. PATIENT UNDERWENT LUMBAR SACRAL FUSION IN THE PRIOR SURGERY. IT WAS REPORTED THAT THE HEAD OF SCREW POPPED OFF WHILE SURGEON WAS TIGHTENING THE PREVIOUSLY IMPLANTED SCREW. THE SCREW WAS REPLACED. 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 16671913 ↗
• InjuryJul 29, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. LEVELS IMPLANTED: L5-S1 PRE-OPERATIVE DIAGNOSIS: PAIN IN THE LEGS AND HARD GOING TO THE RESTROOM, MOVEMENT IN THE DISC SPACE IT WAS REPORTED THAT THE L5 SCREWS FELT SOLID BUT THE S1 SCREWS WERE A BIT LOOSE AND WERE THEREFORE CHANGED. PSEUDARTHROSIS WAS REPORTED IN THE PATIENT. SOME FUSION OCCURRED BUT NOT COMPLETELY. THE PATIENT COMPLAINED FROM PAIN AND A STANDING X-RAY WAS DONE WHERE MOVEMENT WAS NOTICED AND THE PATIENT PLANNED FOR REVISION DUE TO THAT. THE PATIENT WAS ON PAIN MEDICATION. TWO S1 SCREWS WERE REMOVED AND THE AREA AROUND THE DISC SPACE AND THE FACETS WAS DECORTICATED. THE PATIENT'S ISSUE HAS BEEN RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED REGARDING THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 15128044 ↗

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.