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

Model Number	C01A
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having vertebroplasty procedure for an osteoporotic condition on the sacrum.It was reported that the first box of cement was mixed for 1 minute and injected at 5.5-6 minutes, but the cement had already hardened, resulting in no cement being injected.The second box was mixed for 45 seconds and injected at the 3.5-minute mark; small amounts of cement were able to be injected before the cement hardened.Computed tomography was used to check cement placement and the amount injected, revealing small amounts of cement at the posterior border of the sacrum surrounding the working port.The procedure was completed successfully with the original product.No patient symptoms/complications have been reported as a result of this event.Additional information was received that the procedure that was involved was bilateral sacroplasty.The third box of cement is the same batch as the previous one, this is batch where most cement are injected into the patient body.The mixing process and insertion process is much earlier than the previous ones.The mixing time was 30 seconds and was injected right after loading.The remnant cement of the third batch was hardened at 3minutes 30 seconds to 4minutes.
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.

• 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: 24311230
• Report Number: 3003120897-2026-00232
• Device Sequence Number: 17535865
• Product Code: NDN
• UDI-Device Identifier: 00643169097865
• UDI-Public: (01)00643169097865(17)280430(10)EL70359
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2026

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: C01A
• Device Catalogue Number: C01A
• Device Lot Number: EL70359
• 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: 01/21/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2025
• 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: Male