MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHX HV-R BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Catalog Number C01A

Device Problem Migration (4003)

Patient Problem Pulmonary Embolism (1498)

Event Date 12/04/2019

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

It was reported that the patient underwent balloon kyphoplasty due to primary osteoporosis.Intra-operatively, during the operation the cement came into the vein on the side of the vertebral body.After that, the cement solidified.It was confirmed that the cement which came into the vein also solidified.The following day, it was checked when taking ct that the cement was not on the side of the vertebral body but came to the lungs, and has turned to pulmonary embolism.But there were no symptoms.There was no delay in overall procedure time as a result of this event.There were no patient complications as the result of this event.

• Brand Name: KYPHX HV-R BONE CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9537591
• MDR Text Key: 179246961
• Report Number: 1030489-2020-00003
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 00643169097865
• UDI-Public: 00643169097865
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041584
• 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: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C01A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2019
• 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