MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON KIS; ENGINE, TREPHINE, ACCESSORIES, AC-POWERED

Model Number	KE152
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having balloon kyphop lasty for bone metastasis.It was reported that balloons were inflated at l5 level after osteocool ablation.Both balloons popped.The balloon on the patients right side ruptured in the vertebral body and a portion of balloon with distal radiopaque marker remained within the vertebral body.Physician competed the procedure with cement augmentation at this level.The balloon ruptured/popped and the radiopaque marker from the balloon was left inside of the vertebral body.There were no patient symptoms reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
Radiographic image review: multilevel lateral x-ray, cement present in vertebral body.Multiple small numbers consistent with ruptured balloon present in 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: KYPHON KIS
• Common Device Name: ENGINE, TREPHINE, ACCESSORIES, AC-POWERED
• 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: 21994580
• Report Number: 9612164-2025-02318
• Device Sequence Number: 4618617
• Product Code: HRG
• UDI-Device Identifier: 00763000312039
• UDI-Public: 00763000312039
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 05/09/2025
• 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 Age: 73 YR
• Patient Sex: Unknown