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

Catalog Number	C01A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the patient underwent underwent kyphoplasty surgery due to primary osteoporosis and compression fracture.Post-op, in ct scan results it has been identified that the bone cement extravasated into the inferior vena cava (ivc).There were no patient problems at this time.However, in regards to the future, it is that the surgeon of vascular surgery does the operation with the intention of the patient.It is planned to insert the catheter, and remove the cement with grasping the wire.The operation date is currently undecided.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
For the cement ivc leak at (b)(6) hospital obtained in june, there was new information obtained from the doctor.It was said that part of the cement mass leaked to the ivc was separated in two and went to the left and right lung (comminuted into pieces).Ct images had been taken twice every one and a half months, and there was no moving more than that and no symptom at this time.The patient visited this hospital for lower extremity fracture and had operation and hospitalization at another hospital.

• Brand Name: KYPHX HV-R BONE CEMENT
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 8783750
• Report Number: 1030489-2019-00747
• Device Sequence Number: 13870222
• Product Code: NDN
• UDI-Device Identifier: 00643169097865
• UDI-Public: 00643169097865
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K041584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: C01A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention