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

Model Number	KEX152EB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Spinal Column Injury (2081)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G2: country of origin is japan.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from a healthcare provider (hcp) via manufacturer representative regarding spinal product that is used in transcutaneous vertebroplasty.It was reported that when osteo introducer was inserted into the aorta, it got stuck in aorta and bleeding happened.The procedure was discontinued and additionally vascular repair was performed by vascular surgeon.No further complications were reported.Additional information was received via manufacturer representative that during the insertion of the introducer, it punctured the anterior portion of the left l1 vertebral body.Hemorrhaging was observed through the cannula, so a vascular surgeon used a coil to perform compression hemostasis and hemostasis.In order to check the state of the damage, they were placed in a supine position and laparotomy was performed; however, there was no damage to the aorta and hemostasis was performed, so the wound closure/surgical incision closure without any further action.As a result, the branching vessels were damaged, not the aorta.There was no human factors or no device malfunction as the cause of vascular damage.The condition is currently improving and revision surgery (bkp) is not scheduled.Underlying disease: compression fracture due to external injury (fall) comorbidities: lumbar spinal canal stenosis (lscs) bkp performed vertebral body: l1 hemorrhaging: 100 cc.

• 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: 19747892
• Report Number: 9612164-2024-03242
• Device Sequence Number: 6532173
• Product Code: HRX
• UDI-Device Identifier: 00763000026912
• UDI-Public: 00763000026912
• 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): 07/16/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2025
• Device Model Number: KEX152EB
• Device Catalogue Number: KEX152EB
• Device Lot Number: 227273483
• 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: 06/17/2024
• Initial Report FDA Received Date: 07/16/2024
• Date Device Manufactured: 09/20/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown