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

Model Number	KPX203RB
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having kyphoplasty for t12 vertebral compression.It was reported that the doctor accessed the level of the vertebral compression t12 according to the instructions using the left pedicle only.He then deployed a single balloon through the access port and asked for the cement to be mixed.When the cement was determined to be ready to inject, the doctor injected about 1cc of cement, then retracted the bone filler device, and proceeded to use the curette to spread the cement outward from its original point of injection.Then he removed the curette, and reinserted the balloon catheter into the working cannula to further spread the cement and impact into the vertebral body bone.Upon doing so, he noticed the balloon had broken.He noted he had filled the balloon with 2cc of contrast and up to 100psi of pressure.He then drew back on the inflation syringe handle to remove as much of the contrast as possible, then pulled out the ballloon cather.Upon doing so he noticed the lead half of the balloon had not come out.He then attempted to retrieve the front half of the balloon using the currette.He was unable to retrieve the balloon fragment.He then attached the locking syringe to a bone filler device and attemted to suction the balloon fragment, but that failed to do so.These attempts took less than 1 minute to attempt and complete.He then proceeded to inject cement according to the instructions for use using the remaining mixed cement and bone filler de vices.He determined a sufficient amount of cement had filled the vertebral body to provide fixation. there was no patient symptom reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
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 XPANDER 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: 18938824
• Report Number: 9612164-2024-01326
• Device Sequence Number: 7042616
• Product Code: HRX
• UDI-Device Identifier: 00763000031626
• UDI-Public: 00763000031626
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K101864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2024

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: 03/30/2025
• Device Model Number: KPX203RB
• Device Catalogue Number: KPX203RB
• Device Lot Number: 227096513
• 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: 02/28/2024
• Initial Report FDA Received Date: 03/20/2024
• Date Device Manufactured: 08/09/2023
• 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 Age: 82 YR
• Patient Sex: Female