MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO., HU CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	55740107550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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 assessment for the this event possible related to the index surgery and causal related to the device.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO., HU; road 909, km. 0.4; humacao,pr
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO., HU; road 909, km. 0.4; humacao,pr
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 24604149
• Report Number: 2647346-2026-00144
• Device Sequence Number: 18727849
• Product Code: KWP
• UDI-Device Identifier: 00643169052109
• UDI-Public: (01)00643169052109(17)290828(10)H5969993
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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: 55740107550
• Device Catalogue Number: 55740107550
• Device Lot Number: H5969993
• 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: 02/19/2026
• Initial Report FDA Received Date: 03/16/2026
• Date Device Manufactured: 08/28/2024
• 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; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White