MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON® HV-R® BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Model Number	C01B
Medical Device Problem Codes	Coagulation in Device or Device Ingredient (1096); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
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 kyphon and hvr bone cement with mixer having spinal therapy.It was reported that procedure started out normal with access via pedicles into vertebrae and then osteocool was performed on levels t5 and t11.Once the osteocool was done, the kyphoplasty with balloons was performed without any issues.There was difficulty mixing the bone cement due to lack of familiarity with the equipment.When administering the xpede into the bfds, the cement wasn't coming out and within about 1 minute of it being mixed it hardened in the bone filler and the mixer with plunger.A second xpede kit was opened when this happened and ended with the same result, which at that point a third xpede kit was opened with mixer and within a minute of mixing it, the cement had hardened and the scrub tech broke the top of the mixer off.Additionally, the hvr bone cement was unable to be delivered because it was too warm to work with upon arrival in the ir room.Multiple cement mixer kits (four) were rendered unusable during the procedure.The case was completed using an alternative product from another manufacturer.Hvr- cement hardened faster.Event occurred at back table when setting up the cement.There was no patient involvement reported.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.

• Brand Name: KYPHON® HV-R® 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: 22540162
• Report Number: 1030489-2025-02466
• Device Sequence Number: 7819286
• Product Code: NDN
• UDI-Device Identifier: 00643169097834
• UDI-Public: (01)00643169097834(17)270531(10)0012506300
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K041584
• 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,Followup
• Report Date (Section B): 09/18/2025

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: C01B
• Device Catalogue Number: C01B
• Device Lot Number: 0012506300
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 09/19/2025
• Date Device Manufactured: 10/23/2024
• 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 Sex: Unknown