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

Model Number	KEX102EB
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having vertebral bkp for primary osteoporosis.Type of fracture was compression fracture, intraspine cleft.It was reported that the balloon was ruptured.  after the insertion was placed, it was damaged during the initial expansion period.Damage to the contralateral side continued during expansion.Accessed with needle, then drilled.Inflated after balloon placement.Damaged during expansion.The contralateral side was also damaged.A new kit was unpacked and handled.At that time, a curette was used and reinserted the ibt, but it did not go in.Level at which the implant was performed l3.There were no patient symptoms reported.There were no further complications reported regarding the event.There was a delay in the overall procedure time of less than 60 minutes.Additional information was received from the manufacturer representative that when a new kit was opened and used, and the ibt was reinserted using a curette, but it did not go in.
Additional Manufacturer Narrative
H3: product analysis :part# kex102eb; lot# 226975448 visual and functional inspection revealed the balloon has been punctured.The damage is a slice in the lower portion of the balloon.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): 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 19535853
• Report Number: 9612164-2024-02823
• Device Sequence Number: 12368381
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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: 04/04/2025
• Device Model Number: KEX102EB
• Device Catalogue Number: KEX102EB
• Device Lot Number: 226975448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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