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

Model Number	6973050
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: event date is unknown d4: lot number is unknown 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 user facility via a manufacturer representative regarding the devices used for cervical arthroplasty p rocedure.It was reported that there was a loss of elasticity in the inserter shaft, resulting in inability to grab the implant, and slight damage to one of the blades of the rail punch, causing issues when creating keels in the vertebrae.Instrument breakage was identified for both the inserter shaft and rail punch.There was no patient involved.
Event or Problem Description
Additional information was received that the actual allegation was the bent rail cutter will not cut straight and bent inserter will not insert.
Additional Manufacturer Narrative
H3: product analysis of product:6973050, lot:em17h003 visual and optical inspection confirmed the inner shaft inserter is worn from repeated use.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: 24361502
• Report Number: 1824199-2026-00022
• Device Sequence Number: 4836183
• Product Code: MJO
• UDI-Device Identifier: 00613994714831
• UDI-Public: (01)00613994714831(11)171022(10)EM17H003
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P090029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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: 6973050
• Device Catalogue Number: 6973050
• Device Lot Number: EM17H003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown