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

Model Number	436013D
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy.It was reported that during a spinal procedure involving the technical team encountered several issues.Initially, after breaking off the verify tab and loading the device onto the inserter, the device could not be collapsed.Multiple attempts were made to reconnect the inserter, and eventually, the lock screwdriver was used to loosen the locking mechanism, allowing the device to collapse and expand.During the expansion, a crunching sound was heard, and upon attempting final tightening, a grinding sound was noted.The device failed to maintain its expansion and was subsequently removed.There were no patient complications or symptoms have been reported as a result of this event.Additional information was received via manufacturer representative that patient had a prior emergency surgery at another facility due to losing motor and sensory functions.An emergency laminectomy was done to alleviate the pressure on the spinal cord and try to restore functions.The patient eventually now came with a kyphosis of the cervical spine and infection.A two level anterior cervical corpectomy (c4 and c5) was needed to remove the affected anatomy and placement of an expandable cage as well as a cervical plate and screws to support and correct the cervical spine in a more natural alignment.Initially, it was unknown whether it was the cage or the inserter that was the issue.When we opened a second identical set and tried the new set¿s inserter, the same issue occurred on the back table but when new set of same size cage was used with initial inserter, it functioned normally.Hence, there was no issue or malfunction associated with inserter.
Additional Manufacturer Narrative
H3: product analysis of part# 436013d, lot# ca23f175 visual and optical inspection of the centerpiece expander did not reveal any damages that would hinder the implant from expanding.Optical inspection revealed a few of the gears/teeth has been damaged and deformed.Functional inspection with a sample 13mm inserter confirmed the implant was able to connect and engage, expand and close without any grinding or restrictions.The implant body set screw may have been locked down causing the teeth/gears to be stripped during 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.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: 22000466
• Report Number: 1030489-2025-01946
• Device Sequence Number: 18402811
• Product Code: MQP
• UDI-Device Identifier: 00763000856274
• UDI-Public: (01)00763000856274(11)241022(10)CA23F175
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: 436013D
• Device Catalogue Number: 436013D
• Device Lot Number: CA23F175
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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: Female