MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. MODULEX SHANK CDG SLEEVE; DISPENSER, CEMENT

Model Number	6550044
Medical Device Problem Codes	Mechanical Problem (1384); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
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 multiple sources (manufacturer representative, user facility) regarding a patient having spinal therap y.It was reported that the six guides had the cement stuck in the sleeve and for the four guides cement stuck inside the device.There was no patient involved.
Additional Manufacturer Narrative
Additional review of the event shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements in 21 cfr 803.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: MODULEX SHANK CDG SLEEVE
• Common Device Name: DISPENSER, CEMENT
• 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: 23307158
• Report Number: 3003120897-2025-00375
• Device Sequence Number: 20075498
• Product Code: KIH
• UDI-Device Identifier: 00763000712013
• UDI-Public: (01)00763000712013(11)240823(10)K24H1153
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 02/17/2026

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: 6550044
• Device Catalogue Number: 6550044
• Device Lot Number: K24H1153
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 02/17/2026
• Date Device Manufactured: 08/23/2024
• 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