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

Catalog Number K13A

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/06/2020

Event Type  malfunction  

Manufacturer Narrative

Product was not 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

It was reported that the patient presented with compression fracture and metastatic osteoncus; and underwent percutaneous kyphoplasty at t10.Intra-op, it was noticed that the balloon had shrunk a little during cement mixing.It occurred when the ibt was inserted into the vertebral body, balloon was expanded and cavity was created.It seemed that the contrast media was leaking a little from the vicinity of the connection part between the ibt and the syringe with tube.The negative pressure condition in the state that ibt and the syringe with tube were combined was checked but the display showed ""0"" instead of ¿--¿.The ibt was removed from the inflation syringe, and the air was removed from the ibt.When attachment was performed again, the display indicated "--", so the product was inserted into the patient¿s body, and balloon expanding was performed.The procedure was completed with the same product.There were no patient complications as a result of this event.

• Brand Name: KYPHON XPANDER INFLATABLE BONE TAMP
• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 10027825
• MDR Text Key: 190601854
• Report Number: 9612164-2020-01780
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: K13A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: No
• 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