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

Model Number	CX01A
Medical Device Problem Codes	Coagulation in Device or Device Ingredient (1096); Product Quality Problem (1506)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/06/2026
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 an healthcare provider (hcp) via manufacture representative regarding a product used in osteocool spinal therapy for thoracic pain, metastasis to vertebral body at level t11.It was reported that during an osteocool case involving mixer and cement, surgeon experienced significant difficulty mixing the bone cement despite following proper technique and labeling instructions.The cement did not achieve the normal smooth consistency, and large chunks of powdered cement were observed stuck to the mixer.After the initial mixing, only 1-2 cc of cement could be extruded into cartridges before it became very difficult to push out anymore.Both were unable to push more than 1 cc of cement into the egg, and two sets of previously mixed cement were discarded by the facility.The issue was resolved by assembling a new cement kit and using the included syringe and needle to draw up the liquid component, which resulted in easier mixing and the correct consistency.The cement was then successfully delivered via cds gun and bone filler without further issue.There were no further complications or symptoms reported regarding the event.Additional information was received via manufacturer representative that procedure was completed successfully but patient did not experience significant pain relief from procedure.

• 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: 24243484
• Report Number: 3003120897-2026-00165
• Device Sequence Number: 9618731
• Product Code: NDN
• UDI-Device Identifier: 00643169097803
• UDI-Public: (01)00643169097803(17)280630(10)EL70370
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K102397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/03/2026

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: CX01A
• Device Catalogue Number: CX01A
• Device Lot Number: EL70370
• 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: 01/06/2026
• Initial Report FDA Received Date: 02/03/2026
• Date Device Manufactured: 09/02/2025
• 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