MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. T2 STRATOSPHERE¿ Expandable Corpectomy System; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	436013B
Medical Device Problem Codes	Mechanical Problem (1384); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from distributor via a manufacturer representative regarding a patient having c3-5 corpectomy requiring str uctural interbody reconstruction.It was reported that during the procedure, a expandable mesh cage was positioned and expanded in accordance with the manufacturer's technical manual.During attempted final locking of the expanded mesh construct, the internal locking screw mechanism failed, and the locking screw threads stripped continuously, preventing proper torque delivery and complete locking and fixation in the final position.The expandable mesh cage was explanted, removed, and discarded.A same-size replacement implant was deployed and successfully locked.No patient complications have been reported as a result of this event.
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.

• Brand Name: T2 STRATOSPHERE¿ Expandable Corpectomy System
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; +1(763)526-5677
• MDR Report Key: 50865556
• Report Number: 3003120897-2026-01604
• Device Sequence Number: 10661341
• Product Code: MQP
• UDI-Device Identifier: 00643169663121
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K173125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 436013B
• Device Catalogue Number: 436013B
• Device Lot Number: CA20B022
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 10/27/2020
• 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
• Patient Sex: Unknown