MAUDE Adverse Event Report: MITG - TIJUANA KYPHON EXPRESS¿ II INFLATABLE BONE TAMP; ARTHROSCOPE

Model Number	KEX152EB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from user facility via manufacturing representative regarding a product identified during an event.It was reported that balloon broke.Procedure involved was balloon kypho plasty.No patient symptoms due to this event.No further complications were reported/anticipated.
Additional Manufacturer Narrative
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
H3:product analysis #(b)(4):part # kex152eb;lot # 231122646 visual and optical inspection revealed the tip of the balloon has been damaged.The lower portion of the balloon has been sliced.This damage is consistent with the balloon coming in contact with bone spurs when the balloon is inflated in the vertebral body.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.

• Brand Name: KYPHON EXPRESS¿ II INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MITG - TIJUANA; blvd. insurgentes parcela #37; tijuana, bc 22570 ; MX 22570
• Manufacturer (Section G): MITG - TIJUANA; blvd. insurgentes parcela #37; tijuana, bc 22570 ; MX 22570
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 22663212
• Report Number: 2936999-2025-00399
• Device Sequence Number: 19758356
• Product Code: HRX
• UDI-Device Identifier: 00763000026912
• UDI-Public: (01)00763000026912(17)261210(10)231122646
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2025

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 Model Number: KEX152EB
• Device Catalogue Number: KEX152EB
• Device Lot Number: 231122646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 09/06/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 10/02/2025
• Date Device Manufactured: 04/15/2025
• 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