MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. SMALL INSERTER SHAFT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	7967079
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
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 user facility via a manufacturer representative regarding a patient having spinal therapy.It was repo rted that instrument breakage occurred with the inserter during spinal surgery.The product was utilized correctly according to the instructions for use.No fragment of the instrument remained in the patient.There was no patient involved.Additional information was received from the manufacturer representative that the sovereign inner shaft broke during insertion of a small sovereign implant.The inner shaft broke near the handle on the third or fourth time it was struck with a mallet.This particular inserter has been used for many cases.The implant wasn¿t quite in final positioning yet.We use the position adjuster or secondary impactor to place the implant in perfect position.The patient was unharmed.The case went very well other than the inserter breaking.
Additional Manufacturer Narrative
H3: product analysis of product: 7967079, lot: em16j023.Visual and microscopic examination confirmed that the shaft was broken.This is consistent with excessive force.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: SMALL INSERTER SHAFT
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• 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: 23713973
• Report Number: 3003120897-2025-00680
• Device Sequence Number: 8910835
• Product Code: MAX
• UDI-Device Identifier: 00613994545305
• UDI-Public: (01)00613994545305(11)170107(10)EM16J023
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K091813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: 7967079
• Device Catalogue Number: 7967079
• Device Lot Number: EM16J023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown