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

Model Number KEX152EB

Device Problems Leak/Splash (1354); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/25/2023

Event Type  malfunction  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from an unknown source regarding a patient having lumbar laminoplasty for primary osteoporosis.It was reported that balloon on the right side of the vertebral body ruptured when the balloon was inflated after opening one new bkp kit and initial insertion into the vertebral body.The ibt inserted on the left side could not guarantee product safety, so the balloons on both sides were collected.Vertebral body formation was not achieved, so a new bkp1 kit was unpacked and the operation was advanced.However, the balloon on the right side of the vertebral body ruptured again under the same conditions as in the first kit when it was initially inserted.Because the rupture occurred during expansion, vertebral body formation has not yet been completed, hence the bkp1 kit was newly opened and the operation was advanced with the same reason as before.The third kit did not rupture. cement was inserted into the mixer and mix with paddles, but the paddles did not rotate and could not be mix.A new mixer was unboxed and used. there were no patient symptoms reported.There were no further complications reported regarding the event.Additional information was received from the manufacturer representative that when the balloon ruptured, the contrast agent leaked into the body, but there was no health hazard to the patient.

• Brand Name: KYPHON EXPRESS¿ II INFLATABLE BONE TAMP
• Type of Device: 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: 18568390
• MDR Text Key: 333539291
• Report Number: 9612164-2024-00378
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00763000026912
• UDI-Public: 00763000026912
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2024

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
• Device Operator: Health Professional
• Device Model Number: KEX152EB
• Device Catalogue Number: KEX152EB
• Device Lot Number: 227096487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/25/2023
• Initial Date FDA Received: 01/24/2024
• Date Device Manufactured: 08/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1