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

Model Number	KEX102EB
Medical Device Problem Codes	Difficult to Insert (1316); Product Quality Problem (1506); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G2: country of origin is japan.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.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 transcutaneous vertebroplasty spinal therapy for primary osteoporosis.It was reported that the balloon was not advancing well, so it was removed once; when an attempt was made to reinsert it after the drill, the balloon got stuck in the osteointroducer and could not be inserted into the vertebral body.There were no further complications reported regarding the event.Additional information was received via manufacturer representative that it was distorted due to the weak core of the balloon when the load was put the balloon inserted into the vertebral body after the drill.

• 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: 20236733
• Report Number: 9612164-2024-04250
• Device Sequence Number: 18153254
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2024

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: 08/14/2025
• Device Model Number: KEX102EB
• Device Catalogue Number: KEX102EB
• Device Lot Number: 227492612
• 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: 08/20/2024
• Initial Report FDA Received Date: 09/17/2024
• Date Device Manufactured: 10/16/2023
• 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