MAUDE Adverse Event Report: WARSAW ORTHOPEDIC, INC. CD HORIZON® SOLERA® VOYAGER¿ Spinal System; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	651000040
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having open surgery spinal therapy for degenerative spine condition.It was reported that during the procedure, difficult rod placement was encountered.The loaner set intended for the voyager 4.75 mm system had been replenished with voyager 5.5 mm implants, and wrong-diameter rods were placed.The surgeon was unable to lock the system with the locking nuts.The planned minimally invasive surgery was converted to open surgery, and the wound was opened on one side to remove the incorrect rods.The incorrect rods were explanted and replaced.Surgical time was extended by approximately 1 hour.There were unknown patient symptoms or complications reported.Additional information received from the manufacturer representative that there was no patient symptoms reported.Additional information received from the manufacturer representative that the levels involved was l5-s1.The quantity of the reported products were 2 minimal invasive rods 5.5.
Additional Manufacturer Narrative
B2: the planned minimally invasive surgery was converted to open surgery, and the wound was opened on one side to remove the incorrect rods.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: CD HORIZON® SOLERA® VOYAGER¿ Spinal System
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 50850147
• Report Number: 1824199-2026-00095
• Device Sequence Number: 9923285
• Product Code: NKB
• UDI-Device Identifier: 00643169748521
• UDI-Public: (01)00643169748521(11)260203(10)1094574W
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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: 651000040
• Device Catalogue Number: 651000040
• Device Lot Number: 1094574W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/22/2026
• Supplement Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 02/03/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown