MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. T2 STRATOSPHERE¿ EXPANDABLE CORPECTOMY SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	436025300
Medical Device Problem Codes	Mechanical Problem (1384); Product Quality Problem (1506)
Health Effect - Clinical Code	Oversedation (1990)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G2: country of origin is australia.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 healthcare provider (hcp) via a manufacturer representative regarding products used in spinal therapy.It was reported that during a spinal procedure, the cage would not expand fully and would not collapse fully, and the endcap would only attach on one side and kept falling off.These issues added considerable time to the operation, exposing the patient to multiple passes of instrumentation past nerve roots and unnecessary exposure to anesthetic.Both products were explanted in same surgery.There were no further patient complications or symptoms have been reported as a result of this event.Additional information was received via manufacturer representative that the provisional locking ring on the inserter locks the grub screw on the center strut.Pre-op diagnosis of patient was l3 burst fracture, procedure involved in the event was l3 corpectomy, levels implanted was l3 and there were no patient complication to note but it did add 90 mins to the surgery.
Additional Manufacturer Narrative
H3: product analysis of part# 436025300, lot# ca19f189 visual and optical examination revealed the locking tab bent from what appears to be overload.This is consistent with overload.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 ; 7635265677
• MDR Report Key: 23463908
• Report Number: 3003120897-2025-00493
• Device Sequence Number: 9084444
• Product Code: MQP
• UDI-Device Identifier: 00643169651074
• UDI-Public: (01)00643169651074(11)200125(10)CA19F189
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: 436025300
• Device Catalogue Number: 436025300
• Device Lot Number: CA19F189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2020
• 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: Required Intervention
• Patient Sex: Male