MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON EXPRESS II INFLATABLE BONE TAMP; ARTHROSCOPE

Model Number	KEX102EB
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G2: the country of the event is japan.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 patient having l3 bkp for an i ndication of primary osteoporosis compression fracture.It was reported that the be balloon was ruptured. the cement was mixed with the 3cc balloon inflated and when the viscosity became appropriate and deflation was performed, it was discovered that a contrast agent mixed with blood had returned to the syringe.A new kit was opened again and the balloon was inflated to check the cavity.The cement had already solidified, so an additional set was opened with the mixer.There was a delay of less than 60 mins reported. there was no patient symptom reported.There were no further complications reported regarding the event.

• Brand Name: KYPHON EXPRESS II 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: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 20618406
• Report Number: 9612164-2024-05091
• Device Sequence Number: 15337126
• Product Code: HRX
• UDI-Device Identifier: 00763000026882
• UDI-Public: 00763000026882
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123771
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2024

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: 06/04/2025
• Device Model Number: KEX102EB
• Device Catalogue Number: KEX102EB
• Device Lot Number: 227257418
• 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: 10/10/2024
• Initial Report FDA Received Date: 11/06/2024
• Date Device Manufactured: 08/30/2023
• 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