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

Model Number	KEX102EB
Medical Device Problem Codes	Material Twisted/Bent (2981); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A: select patient information cannot be included in regulatory report due to regional privacy regulations.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 percutaneous vertebroplasty (pvp) for an indication of primary osteoporosis (compression fracture).It was reported that while confirming the condition of the expanded balloon under frontal fluoroscopy, an attempt was made to remove the stylet, but it could not be removed.The stylet on the right side got stuck.When inflating the balloon, it was pulled forward, so it was inflated once, deflated, and then inflated again.The left side was inflated normally.Although the left side was tight, the stylet was somehow removed.The right side could not be removed, and the balloon was deflated to remove it entirely.After removal, the stylet was pulled and found to be bent.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: 21393761
• Report Number: 9612164-2025-00851
• Device Sequence Number: 8471377
• 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): 02/18/2025

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: 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: 01/24/2025
• Initial Report FDA Received Date: 02/18/2025
• 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