MAUDE Adverse Event Report: WARSAW ORTHOPEDIC, INC. PRESTIGE® CERVICAL DISC SYSTEM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	6972870
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
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) spinal fusion procedure in a patient (patient id: (b)(6).Patient medical history: arthritis, hyperlipidemia, hypertension it was reported that, post cranial spine surgery c6-c7, as per investigator assessment it was confirmed that implanted devices does not appear stable and secure.The patient experienced evidence of implant subsidence postoperatively.The event is suspected to be device-related due to anatomical and biomechanical mismatch.The patient is approximately 7 feet tall, and the largest available implant was used; however, it did not provide full endplate coverage and resulted in an anterior shift of the centre of rotation.This suboptimal implant positioning and size may have contributed to increased axial load concentration and inadequate load distribution across the endplate, leading to implant settling or sinking (subsidence) into the vertebral body.The subsidence was not immediately evident intraoperatively but was later confirmed on follow-up imaging obtained at the 1-month follow-up visit on (b)(6) 2025. there was no patient symptom reported.There were no further complications reported regarding the event.

• Brand Name: PRESTIGE® CERVICAL DISC SYSTEM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• 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: 22920420
• Report Number: 1824199-2025-00032
• Device Sequence Number: 9079364
• Product Code: MJO
• UDI-Device Identifier: 00613994493620
• UDI-Public: (01)00613994493620(17)270410(10)0720896W
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P090029
• 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): 08/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6972870
• Device Catalogue Number: 6972870
• Device Lot Number: 0720896W
• 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: 08/07/2025
• Initial Report FDA Received Date: 08/29/2025
• Date Device Manufactured: 04/10/2019
• 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
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 156 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White