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

Model Number KEX152EB

Device Problems Break (1069); Leak/Splash (1354); Material Rupture (1546); Mechanical Jam (2983)

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

Event Date 12/06/2023

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 a healthcare professional via a manufacturer representative regarding a patient with preoperative diagnosis for primary osteoporosis.Type of fracture compression fracture.Bkp therapy was performed.Level at which implant performed was l2.It was reported that the be balloon breakage.Both sides of the balloon were placed after the implantation of the osteo introducer.At that time, the balloon was placed smoothly without pushing it in very hard.A balloon was inflated at half a turn under the image on the side, and the image was checked as needed.Both sides were extended to approximately 1.5 cc to 2.0 cc.The maximum pressure during inflation is 200 to 250 psi.On the image, it expanded in a good way.The stylets were removed on both sides to check the front image, but only the right side could not be removed.It was pulled very strongly and came out about 2c, but it could not be removed any further.The front view of the image was checked while carefully avoiding the balloon.Confirmed that the right side of the balloon had ruptured.The image was to the side and the left balloon was removed.The right balloon was also tried to be removed, but the balloon could not be removed from the osteo introducer.As a result, the balloon was removed along with the osteo introducer.The procedure was performed from the beginning using the newly unboxed kpt1502; afterwards, it was completed without any problems.There was no patient symptoms or complications as a result of this event.There was a delay of less than 60 minutes.Additional surgery performed as a result of this event.The bkp system was changed to kpt1502 and treated.After the balloon was inflated, tried to pull out the stylet, but it would not come out no matter how hard it was pulled.Subsequently, contrast agent leakage from the balloon was confirmed in the frontal image.When tried to pull the ibt out of the osteo introducer, the balloon got stuck in the osteo introducer and could not be pulled out.As such, the osteo introducer together with the ibt was removed from the vertebral body.When the balloon got stuck on the osteo introducer and could not be removed, the image was checked, and found that there were two markers near the tip of the osteo introducer.When looking at the removed ibt, saw that the inner tube had separated from the tip of the balloon (based on the image, it seems that the separated part was stuck inside the ibt shaft).

Manufacturer Narrative

Corrected section b1.Corrected section h1.From serious injury to malfunction corrected section h6 (fdd code).Corrected imf code.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.

Manufacturer Narrative

H3.Product analysis product id # kex152eb; lot no.# 227258590 visual inspection confirmed one of the ibt is stuck in the introducer and the other is able to be inflated and deflated as intended.The balloon appears to have been damaged in the vertebral area causing the balloon leak.The balloon appears to be deformed and not able to be pulled back through the introducer due to the dried media.The damage to the balloon is consistent with 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
• 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: 18395919
• MDR Text Key: 331358244
• Report Number: 9612164-2023-06167
• 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,Followup,Followup
• Report Date: 05/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KEX152EB
• Device Catalogue Number: KEX152EB
• Device Lot Number: 227258590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/26/2023
• Supplement Dates Manufacturer Received: 03/14/2024; 05/22/2024
• Supplement Dates FDA Received: 03/18/2024; 05/27/2024
• Date Device Manufactured: 09/11/2023
• 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
• Patient Outcome(s): Required Intervention