MAUDE Adverse Event Report: MDT Puerto Rico Operations Co, Med Rel CD HORIZON® Spinal System; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	55840005550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Numbness (2415); Back pain (4895)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider, clinical study) regarding a patient with clinical id (b)(6), study name (b)(6).It was reported that patient had worsening back pain. persistent numbness and pain following spinal fusion surgery, with symptoms suggesting nerve irritation.Imaging shows minimal graft maturation in the posterior spinal fusion from l4 to s1, which may contribute to symptoms.Possible irritation from bone fragments or screw placement affecting l4 and l5 nerve roots.X-ray was performed on (b)(6) 2025, imaging shows minimal graft maturation in the posterior spinal fusion from l4 to s1, which may contribute to symptoms.Possible irritation from bone fragments or screw placement affecting l4 and l5 nerve roots.Ae resulted in external bone growth stimulator treatment.Investigator assessment: causal relationship to study procedure and probable related to a medtronic cst device.Sponsor assessment is same as investigator. outcome of this ae is recovering/resolving.Additional information received.Diagnostic test: xray, on (b)(6) 2025: diagnostic test result: imaging shows minimal graft maturation in the posterior spinal fusion from l4 to s1, which may contribute to symptoms.Possible irritation from bone fragments or screw placement affecting l4 and l5 nerve roots.Outcome of this ae is recovering/resolving.Update received in lsh from merged sr# (b)(6): the adverse event resulted in any treatment, with an external bone growth stimulator used; there was no hospitalization; spinal surgery was performed; and the additional spinal surgery was on (b)(6) 2025.The additional surgery was performed post surgery on (b)(6) 2025 for an adverse event related to the device, specifically the worsening back pain adverse event dated (b)(6) 2025.The procedure was a revision surgery at the l4 spinal level, and mdt cst ailliance eligible devices implanted during the index surgery remained in the subject at the end of the additional spinal surgery.
Additional Manufacturer Narrative
H6: neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CD HORIZON® Spinal System
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT Puerto Rico Operations Co, Med Rel; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer (Section G): MDT Puerto Rico Operations Co, Med Rel; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; +1(763)526-5677
• MDR Report Key: 50057759
• Report Number: 2647346-2026-00406
• Device Sequence Number: 9119326
• Product Code: KWP
• UDI-Device Identifier: 00613994972019
• UDI-Public: (01)00613994972019(11)240209(10)H5930826
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 55840005550
• Device Catalogue Number: 55840005550
• Device Lot Number: H5930826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 07/28/2026
• Date Device Manufactured: 02/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Unknown
• Patient Weight: 119 LB
• Patient Race: White