MAUDE Adverse Event Report: MEDTRONIC MEXICO XPANDER; TAMP

Model Number	K09A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6 - neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.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.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having balloon kyphopl asty procedure (th12) due to primary osteoporosis ( compression fracture).It was reported that after insertion, expansion and verification of the front and side views were performed.While the balloon was expanded inside the body, cement mixing was conducted.Upon checking the cement viscosity and at the timing of deflating the balloon, blood backflow into one of the ibts was observed, indicating balloon damage.The other ibt was used without any issues.Since no contrast medium shadow was detected on the image in the fully deflated state, it was assumed there were no residuals inside the body, and the procedure was continued.It was noted that significant bone sclerosis had progressed, and only 1.5cc of cement could be filled at a time, leading the physician to comment that the bone might have been hard.Balloon ruptured during contraction.Pre- rupture pressure was not 200 psi or greater.There were no patient symptoms reported.There were no further complications reported regarding the event.

• Brand Name: XPANDER
• Common Device Name: TAMP
• 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: 22068349
• Report Number: 9612164-2025-02536
• Device Sequence Number: 9394469
• Product Code: HXG
• UDI-Device Identifier: 00763000311919
• UDI-Public: 00763000311919
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K041454
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

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: K09A
• Device Catalogue Number: K09A
• 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: 05/02/2025
• Initial Report FDA Received Date: 05/22/2025
• 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