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

Model Number KPX153RB

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

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

Event Date 10/25/2021

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare provider (hcp) via a manufacturer representative regarding an event which occurred during a kyphoplasty procedure in a patient diagnosed with l2 fracture.It was reported that the tamp ruptured and the contrast media leaked.The area was flushed and the procedure was completed using a new product.There was no patient injury/symptom reported.

• Brand Name: KYPHON XPANDER¿ 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: 12818097
• MDR Text Key: 283435489
• Report Number: 9612164-2021-04419
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00763000031589
• UDI-Public: 00763000031589
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2023
• Device Model Number: KPX153RB
• Device Catalogue Number: KPX153RB
• Device Lot Number: 222044072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2021
• Date Device Manufactured: 04/16/2021
• 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 Sex: Female