MAUDE Adverse Event Report: WARSAW ORTHOPEDIC, INC. VOYAGER FENESTRATED SCREWS; DISPENSER, CEMENT

Model Number	6550202
Medical Device Problem Codes	Leak/Splash (1354); Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis: part # 6550202; lot # k24m6065 visual inspection confirmed cement leakage on the fns tip.The leakage likely resulted from a failed attempt to deliver the cement into the vertebral body.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.
Additional Manufacturer Narrative
E1: initial reporter details are unknown g2: country of origin is japan 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 at th12 for thoracic vertebral fracture.It was reported that cement was filled after screw insertion.Partial leakage to the screw head during cement filling.There were no patient symptoms reported.There were no further complications reported regarding the event.Additional information was received that after inserting the screw, a delivery guide with a tip was attached, and filled 1cc of cement with the delivery device.After 3 minutes, when the delivery guide was removed, part of the cement was attached to the screw head and the tip of the tip.It was not a leak that could be confirmed in the image.Guide wire has also passed, the axis was captured, the green line of the delivery guide was below the black line of the extender, and there was no problem.Additional information was received that there was no malfunction with the cement.
Additional Manufacturer Narrative
H6: annex a code correction.A050701 code is now not considered as there were no problems with the connection of screw and fns tip.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: VOYAGER FENESTRATED SCREWS
• Common Device Name: DISPENSER, CEMENT
• Manufacturer (Section D): WARSAW ORTHOPEDIC, INC.; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDIC, INC.; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 22607541
• Report Number: 1824199-2025-00005
• Device Sequence Number: 5494523
• Product Code: KIH
• UDI-Device Identifier: 00763000211035
• UDI-Public: (01)00763000211035(17)330404(10)H6044657
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2025

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: 6550202
• Device Catalogue Number: 6550202
• Device Lot Number: K24M6065
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 07/28/2025; 10/06/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/22/2025; 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2025
• 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: Unknown