MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON EXPRESS¿ II INFLATABLE BONE TAMP; ARTHROSCOPE

Model Number	KEX102EB-CDS-
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare provider (hcp) via a manufacturer representative regarding a cds kit used on a patient having spinal therapy for a vertebral compression fracture.It was reported that the balloon ruptured during inflation.It ruptured in such a way that the entire circumference sheered off.This caused the balloon to get stuck in the patient and the tip broke off in the patient.With no way to retrieve the balloon fragment it had to be left in the patient and cement was injected around it.There was no cement leak in patient.There was a delay of less than 60 mins in the procedure.Levels implanted was t7 and t8.There was no plan to remove the balloon fragments from the patient.The procedure was completed successfully with the given product.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
H3: product analysis # (b)(4): part # kex102eb-cds, lot # 0227784440 visual and optical inspection revealed the tip of the balloon has been damaged.The upper portion of the balloon is missing.This damage is consistent with the balloon coming in contact with bone spurs when the balloon is inflated in the vertebral body.The upper portion of the balloon appears to have been torn away during the removal process.This regulatory report is being submitted due to retrospective review through capa 624392.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: KYPHON EXPRESS¿ II INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• 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: 21456815
• Report Number: 1030489-2025-00995
• Device Sequence Number: 20829819
• Product Code: HRX
• UDI-Device Identifier: 00643169671621
• UDI-Public: 00643169671621
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K123771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2025

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 Expiration Date: 08/26/2024
• Device Model Number: KEX102EB-CDS-
• Device Catalogue Number: KEX102EB-CDS-
• Device Lot Number: 0227784440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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: Female