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 Codes	Extravasation (1842); Pain (1994); Discomfort (2330); Spinal Cord Injury (2432); Ambulation or Postural Difficulties (2544)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy.Pre-op diagnosis of patient was compression fracture.It was reported that, cement extravasated back through posterior wall behind vertebral body.The levels implanted were t7.Procedure or technique performed was kyphoplasty.As a result of cement extravasation, patient suffered increased pain and as an additional procedure surgery was performed to remove 1 pedicle and clean out cement due to minor compression on cord.Patient was hospitalized.No further complications reported regarding the event.
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.
Additional Manufacturer Narrative
Additional information: a1, b5, h6.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
Additional information received from manufacturer representative stating the cement was extravasated below the vertebral body and into disc space of t7-t8.Additional procedure was performed on (b)(6) 2024.Patient suffered discomfort and loss of balance and function.No further complications reported.

• 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: 19748419
• Report Number: 1030489-2024-00840
• Device Sequence Number: 6513302
• Product Code: NDN
• UDI-Device Identifier: 00763000590970
• UDI-Public: (01)00763000590970(17)250930(10)0011554422
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K220131
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: CT01B
• Device Catalogue Number: CT01B
• Device Lot Number: 0011554422
• 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: 06/20/2024
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 01/28/2026
• Date Device Manufactured: 12/15/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female