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

Model Number	6972450
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033); Blurred Vision (2137); Osteopenia/ Osteoporosis (2651); Swelling/ Edema (4577); Exostosis (bone) (4891); Complex regional pain syndrome (4899)
Date of Event	06/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a consumer via manufacturer representative regarding an event happened during post-op of the reported products.It was reported that, patient experienced rash pain across chest, pain, swelling, diagnosed crps type 1, osteophytes in neck, bone above and below implants is deteriorating, blurry vision, headaches, extreme reaction to nickel and cobalt.Cervical discs were implanted at levels c5-c6 and c6-c7.The implants are being removed this month due to titanium allergy.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
B2: other - revision surgery planned to explant the cages.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: 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: 23082371
• Report Number: 1824199-2025-00043
• Device Sequence Number: 4966237
• Product Code: MJO
• UDI-Device Identifier: 00613994493712
• UDI-Public: (01)00613994493712(17)280113(10)0767179W
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P090029/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6972450
• Device Catalogue Number: 6972450
• Device Lot Number: 0767179W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 09/18/2025
• Date Device Manufactured: 01/13/2020
• 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
• Patient Sex: Unknown