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

Model Number	KE152
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: visual and optical inspection revealed the tip of the balloon has been damaged.The upper portion of the balloon has been cut/torn and separated from the lower portion of the balloon and the inner sleeve appears to have been stretched from the removal process from the cannula.The damage is consistent with the balloon coming in contact with bone spurs when the balloon is inflated in the vertebral body and the ibt being pulled back through the canula.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 an event which occurred during f illing cement as part of l2 bkp procedure in a patient diagnosed with compression fracture due to primary osteoporosis.It was reported that ibt only bulged from the insertion site to the head.The balloon ruptured around the upper end plate.After the balloon rupture, the ibt could not be pulled out from the cannula of the osteo introducer, so the ibt stylet was pulled out and then pulled out, but half of the tip of the balloon and the x-ray marker were separated and remained in the body.There was a delay of less than 60 mins.There is no plan for an additional procedure to remove the balloon tip which is in patient's body.There was no patient symptom reported.There were no further complications reported regarding the event.
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.

• 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: 23424961
• Report Number: 2936999-2025-00530
• Device Sequence Number: 21281624
• Product Code: HRX
• UDI-Device Identifier: 00763000312039
• UDI-Public: 00763000312039
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2025

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: KE152
• Device Catalogue Number: KE152
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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