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	Extravasation (1842)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare professional regarding a patient having balloon kyphoplasty for vertebral compression fracture of t7 and t8.It was reported that the scrub mixed the cement for approximately 1.5 minutes.First cartridge: left side.Injected after 10 minutes of working time.No issues were encountered during injection.Visualization was adequate throughout and the cement delivered appropriately.Second cartridge: right side.Injected after 19 minutes of working time.Cement visualization became difficult on fluoro, particularly on the right side.Early in the injection, cement beads were visible due to the ruse of the bfd.However, once the second cartridge was fully engaged, the cement was hardly visible on imaging.Despite limited visualization, a total of 3.5 cc of cement was injected from the second cartridge into the right side.There was cement extravasation.There was no patient symptom reported and no plan of hospitalization or prolongation of existing hospitalization.There were no further complications reported regarding the event.
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.
Additional Manufacturer Narrative
Radiographic image review: 1: poor quality x-ray kyphoplasty cement visualized.2: ap x-ray, some cement fill in two vertebral bodies is seen.A red circle and arrow are present; it is unclear what this describes.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: 22685253
• Report Number: 1030489-2025-02542
• Device Sequence Number: 21119512
• Product Code: NDN
• UDI-Device Identifier: 00763000590970
• UDI-Public: (01)00763000590970(17)270430(10)0012760468
• 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: 0012760468
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 10/08/2025
• Date Device Manufactured: 04/14/2025
• 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 Age: 72 YR
• Patient Sex: Unknown
• Patient Weight: 92 KG