MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON XPANDER¿ INFLATABLE BONE TAMP; ARTHROSCOPE

Model Number	KPT1502
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
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 the healthcare provider (hcp) via a manufacturer representative regarding a kyphon inflatable bone tamp used on the patient having balloon kyphoplasty therapy for primary osteoporosis and compression fracture.It was reported that after 4 rotations on both sides, contrast agent 2cc filling was confirmed.When the cement mixing operation was about to start, the pressure on the right side dropped, and the contrast agent leakage was confirmed on the image. balloon damage was reported. there was a delay of less than 60 minutes in the overall procedure. there were no patient symptoms reported.There were no further complications reported regarding the event.Additional information received that product was inserted into the body and expanded.After expanding the balloon, it was retracted once, the position was adjusted, and when it was expanded again, the pressure gradually decreased, and the leakage of the contrast agent was confirmed.There was no revision surgery planned/ occurred as a result of the event.Balloon was broken.

• Brand Name: KYPHON XPANDER¿ INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 18970329
• Report Number: 9612164-2024-01441
• Device Sequence Number: 6154915
• Product Code: HRX
• UDI-Device Identifier: 00763000031725
• UDI-Public: 00763000031725
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K041454
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2024

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: 08/25/2025
• Device Model Number: KPT1502
• Device Catalogue Number: KPT1502
• Device Lot Number: 227492619
• 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: 02/27/2024
• Initial Report FDA Received Date: 03/25/2024
• Date Device Manufactured: 10/12/2023
• 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: Unknown