MAUDE Adverse Event Report: WARSAW ORTHOPEDIC, INC. ATLANTIS® ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BOD

Model Number	7200025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
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 c7-l1 interbody fusion procedure in a patient.Patient medical history: anxiety and migraine headaches diagnostics: action result: abnormal mild to moderate increased tracer activity is seen in the lower cervical spine at the t7-l1 level.This is similar to the previous bone scan.Motion at this level cannot be excluded.Moderate focal activity is seen in the upper cervical spine at c3-c4 suggesting increased arthritic changes at this level in comparison to the previous bone scan.It was reported that the subject developed a crack at the index fusion site.C7-t1 pseudarthrosis was confirmed intraoperatively.Patient was hospitalized from (b)(6) 2025.Patient underwent additional surgery on (b)(6) 2025 for removal of implants at c4-t1 levels and additional discectomy / hemicortectomy at c7-t1.No product malfunction reported.As per site assessment, event is causally related to study device and study procedure.Patient was administered opiates or narcotics medication.There were no further complications reported regarding the event.Medications administered: medication_name: fentanyl start_date: (b)(6) 2025 dose: 100 dose uom: ug frequency: prn: as needed route: intravenous reason started/indication: anesthesia, additional cervical spine surgery end_date: (b)(6) 2025 medication_name: hydromorphone start_date: (b)(6) 2025 dose: 0.5 dose uom: mg frequency: prn: as needed route: intravenous reason started/indication: pain post-cervical spine surgery end_date: (b)(6) 2025 medication_name: hydromorphone start_date: (b)(6) 2025 dose: 0.25 dose uom: mg frequency: prn: as needed route: intravenous reason started/indication: pain post-cervical spine surgery end_date: (b)(6) 2025 medication_name: ketamine start_date: (b)(6) 2025 dose: 50 dose uom: mg frequency: prn: as needed route: oral reason started/indication: anesthesia, additional cervical spine surgery end_date: (b)(6) 2025 medication_name: oxycodone start_date: (b)(6) 2025 dose: 5 dose uom: mg frequency: prn: as needed route: oral reason started/indication: pain post-cervical spine surgery medication_name: oxycodone start_date: (b)(6) 2025 dose: 10 dose uom: mg frequency: prn: as needed route: oral reason started/indication: pain post-cervical spine surgery end_date: (b)(6) 2025.
Additional Manufacturer Narrative
B2: other: patient had pseudoarthrosis which was causally related to device.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: ATLANTIS® ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BOD
• 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: 23921533
• Report Number: 1824199-2025-00101
• Device Sequence Number: 12967989
• Product Code: KWQ
• UDI-Device Identifier: 00763000889821
• UDI-Public: 00763000889821
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K021461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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): 12/30/2025

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: 7200025
• Device Catalogue Number: 7200025
• 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: 12/10/2025
• Initial Report FDA Received Date: 12/30/2025
• 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: Other; Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White