MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. T2 STRATOSPHERE¿ EXPANDABLE CORPECTOMY SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	NAV4360113
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
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 the connection prongs at the end of the inserter bent and snapped off causing the inserter to no longer be of use and one of the arms of the removal tool snapped off.There were no patient symptoms reported.There were no further complications reported regarding the event.Additional information received from manufacturer representative that the type of procedure involved during the incident was a corpectomy.
Additional Manufacturer Narrative
H3: product analysis of product# (b)(4), lot# rs19e022 visual and microscopic examination confirmed that one of the connection prongs at the end of the inserter was bent.This is consistent with overload.This regulatory report is being submitted due to retrospective review.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: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: 24588007
• Report Number: 3003120897-2026-00481
• Device Sequence Number: 20249487
• Product Code: OLO
• UDI-Device Identifier: 00643169611863
• UDI-Public: (01)00643169611863(11)190904(10)RS19E022
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K191039
• 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
• Report Date (Section B): 03/13/2026

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: NAV4360113
• Device Catalogue Number: NAV4360113
• Device Lot Number: RS19E022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male