MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. KYPHON VUE¿ BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Model Number	CT01B
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6 - the device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.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 for vertebral compression fracture of l1 with biopsy and radiofrequency ablation of l1 for cancer.It was reported that when the cement injection, the right side of the l1 vertebral body showed appropriate cement and barium particle visualization on ap and lateral x-rays.However, when cement was injected on the left side, neither cement nor barium particles were visualized on imaging, despite 2.5cc being injected.This raised concerns for a possible cement leak, particularly given the increased risk of cement extravasation in the presence of a bone tumor.The procedure was completed successfully with the original product, and there was no delay in overall procedure time or need for additional surgery or hospitalization.Ap and lateral x-rays were taken during the procedure to monitor cement fill.The cement was mixed for 45 seconds, was doughy and homogenous prior to delivery, and was stored at the proper temperature.The event was considered related to the use of the product.There were no patient symptoms and complications have been reported as a result of this event.Additional information received from the manufacturer representative that the procedure and levels involved was osteocool and balloon kyphoplasty of l1.
Additional Manufacturer Narrative
Radiographic image review performed by dr hoit and the review comments are as per below.Ap interbody fluoro kyphoplasty level unknown, cement is visualized on the side of the vertebral body, bipedicle access is present.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: KYPHON VUE¿ BONE CEMENT
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• 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: 22562946
• Report Number: 1030489-2025-02475
• Device Sequence Number: 3825901
• Product Code: NDN
• UDI-Device Identifier: 00763000590970
• UDI-Public: (01)00763000590970(17)270103(10)0012460654
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K220131
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2025

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: CT01B
• Device Catalogue Number: CT01B
• Device Lot Number: 0012460654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 10/08/2025
• Date Device Manufactured: 09/25/2024
• 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 Age: 61 YR
• Patient Sex: Female
• Patient Weight: 72 KG