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

Model Number	CX01B
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: neither the device nor films of applicable imaging studies were 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 t9 kyphoplasty spinal therapy for t9 kypho with t9/10 interbody fusion.It was reported that the bone cement with mixer, transpedicular access was obtained into the t9 vertebral body, drilling was performed to the anterior line, a balloon was used to create a cavity, and cement was delivered using 8-gauge bone fillers.Cement extravasation was detected intra-operatively, with cement reported in the spinal canal space from mid t8 to the top of t10, and o-arm spine imaging confirmed cement in the t8¿t10 canal space.There was concern for potential pressure on neural elements from the canal cement, and a laminectomy was performed to relieve potential pressure.A delay in overall procedure time was reported.The procedure was reported as completed successfully with the original product, and cement remained at t9.The cement was reported as used in the patient, stored at proper temperatures, mixed for 30 seconds, and doughy and homogenous prior to delivery.There were no patient symptoms or complications reported as a result of this event.Additional information received from the manufacturer representative that the additional surgery was done because of the procedure not because of the device and the additional time in the procedure was less than 60 min.

• Brand Name: KYPHON® XPEDE¿ 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: 24935469
• Report Number: 3003120897-2026-00739
• Device Sequence Number: 14791650
• Product Code: NDN
• UDI-Device Identifier: 00643169097797
• UDI-Public: (01)00643169097797(17)280930(10)0013240050
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K102397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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: CX01B
• Device Catalogue Number: CX01B
• Device Lot Number: 0013240050
• 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: 03/31/2026
• Initial Report FDA Received Date: 04/21/2026
• Date Device Manufactured: 01/20/2026
• 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: 59 YR
• Patient Sex: Male