MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	54740106535
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received from healthcare provider via manufacturer representative regarding a patient with clinical id: (b)(4), study id: (b)(4), incident type ae subevent number: 0.Primary diagnosis: stenosis description: low back pain onset date: on (b)(6) 2024.Interventions: action subtype: denervation procedure action result: yes action date: on (b)(6) 2024, denervation procedure type: radiofrequency ablation action subtype: ae result in hospitalization action result: no action subtype: any other action(s) taken action result: no action subtype: did the ae result in any treatment action result: yes, action subtype: drug therapy action result: yes, action subtype: injection action result: yes, injection-1: injection name: medial branch block date: on (b)(6) 2024, levels: l3-l4 details: diagnostic injection-2: injection name: medial branch block date: on (b)(6) 2024, levels: l3-l4 details: diagnostic patient outcome: recovering/resolving diagnostic: action type: diagnostic action subtype: were any diagnostic test performed action result: no adverse event info: does the adverse event involve a lumbosacral spinal level: yes, if yes, levels involved: l3-l4 site seriousness assessment: there is no congenital anomaly, death, disability, hospitalization, life threatening and medical intervention, but the severity of adverse event is mild.Site related assessment: it is unlikely related to capstone peek spinal system, posterior supplemental fixation system.Possible related to tlif grafting and study procedure (tlif).Sponsor assessment (oc muo): possible related to the grafting material, posterior fixation system and interbody device.It was reported that the patient had low back pain that radiates down her left leg.Believes it is from physical therapy.It is bother her with everyday activity as the back will tighten.Taking cyclobenzaprine as needed.Additional information was received that description: intermittently radiating low back pain long description: intermittently radiating low back pain l3/l4 site seriousness assessment: there is no congenital anomaly, death, disability, hospitalization, life threatening and medical intervention, but the severity of adverse event is moderate.Additional information was received that adverse event info: does the adverse event involve a lumbosacral spinal level: yes, if yes, levels involved: l3-l4 additional surgical procedure date: 01: on (b)(6) 2024, details surg proc - 01: bilateral radiofrequency ablation is the additional surgical procedure an elective removal - 01: no does the additional surgical procedure involve a spinal level - 01: yes add.Surg: if yes, levels involved - 01: l4-l5 does the additional surgical procedure involve an explant related to the study procedure - 01: no site related assessment: additional surgery is not related to capstone peek spinal system, posterior supplemental fixation system, tlif grafting and unlikely related to study procedure (tlif).Additional information was received that adverse event info: does the adverse event involve a lumbosacral spinal level: yes, if yes, levels involved: l3-l4 additional surgical procedure date: 01: on (b)(6) 2024, details surg proc - 01: bilateral radiofrequency ablation is the additional surgical procedure an elective removal - 01: no does the additional surgical procedure involve a spinal level - 01: yes add.Surg: if yes, levels involved - 01: l3-l4 does the additional surgical procedure involve an explant related to the study procedure - 01: no.
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.
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
Additional information was received that sponsor assessment (oc muo): cec assessed as possible related to the procedure, grafting material, posterior fixation system and interbody device.Interventions: action subtype: surgical treatment action result: yes.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21321535
• Report Number: 1030489-2025-00615
• Device Sequence Number: 8697454
• Product Code: NKB
• UDI-Device Identifier: 00613994976758
• UDI-Public: 00613994976758
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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: 54740106535
• Device Catalogue Number: 54740106535
• Device Lot Number: H5819291
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 05/27/2025
• Date Device Manufactured: 02/06/2023
• 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: 74 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White