MAUDE Adverse Event Report: WARSAW ORTHOPEDIC, INC. PRESTIGE Cervical Disc System; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	6973060
Medical Device Problem Codes	Mechanical Problem (1384); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a device used for cervic al arthroplasty spinal therapy at c5/6.It was reported that the inserters had difficulty seating all four inserter dimples into the interbody.Three of four dimples could be seated, but a snug fit could not be achieved before tightening the locking knob to secure the implant.There was difficulty attaching and locking the implant, including tightening the locking knob.The inserter prongs or dimples were suspected to be bent or unaligned; however, no visible damage was confirmed.There was no patient involved.
Additional Manufacturer Narrative
D4: lot# is unknown; udi 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.

• 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 ; +1(763)526-5677
• MDR Report Key: 50516719
• Report Number: 1824199-2026-00088
• Device Sequence Number: 9375852
• Product Code: MJO
• UDI-Device Identifier: 00613994714848
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P090029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: 6973060
• Device Catalogue Number: 6973060
• Device Lot Number: EM18K028
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 08/31/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2019
• 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