MAUDE Adverse Event Report: WARSAW ORTHOPEDIC, INC. CD HORIZON® SOLERA® SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	654000140
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	11/02/2025
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)(4) l2-l5 interbody fusion procedure in a patient (patient id: (b)(6).Patient medical history: chronic pain, lower urinary tract infectious disease, obesity, primary osteoarthritis of left hip, scoliosis of lumbar spine, unspecified scoliosis type.Interventions: patient was hospitalized from on (b)(6) 2025 for wound irrigation and debridement.It was reported that patient had wound infection after surgery with specific symptoms of wound discharge and visible dehiscence causing wound irrigation and debridement procedure with hospitalization.No product malfunction reported.As per site related assessment, event was possibly related to device and causally related to study procedure.Mri was done which showed fluid collection and surgical wound infection.There were no further complications reported regarding the event.

• Brand Name: CD HORIZON® SOLERA® SPINAL SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): WARSAW ORTHOPEDIC, INC.; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDIC, INC.; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 23816012
• Report Number: 1824199-2025-00098
• Device Sequence Number: 13098986
• Product Code: NKB
• UDI-Device Identifier: 00643169748439
• UDI-Public: 00643169748439
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2025

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: 654000140
• Device Catalogue Number: 654000140
• Device Lot Number: UNKNOWN
• 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: 11/18/2025
• Initial Report FDA Received Date: 12/16/2025
• 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 Sex: Female
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White