MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON XPEDE BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Catalog Number	CX01A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Extravasation (1842)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Outcomes attributed to adverse event: cement extravasation.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 on (b)(6) 2017, the patient underwent kyphoplasty procedure at l5-s1.The procedure consisted of injecting bone cement into the l5 vertebrae on the left side.Reportedly, approximately 17 cm of excess bone cement extruded into the patient's inferior vena cava just after the injection.A subsequent ct scan confirmed that the patient had a linear density measuring approximately 17 cm within his inferior vena cava beginning at the level of the t12 vertebral body and extending inferiorly to the left common iliac vein.Upon received information and belief, the cement retained within patient's vena cava was inoperable.Allegedly, the retained cement could fracture at any time, resulting in perforation of internal structures and another vital organ(s), potentially causing significant injury or death.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The implant date was on or around (b)(6) 2017.

• Brand Name: KYPHON XPEDE 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: 9895034
• Report Number: 1030489-2020-00395
• Device Sequence Number: 701425
• Product Code: NDN
• UDI-Device Identifier: 00643169097803
• UDI-Public: 00643169097803
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K163032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2020

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: CX01A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 03/29/2020
• Supplement Report FDA Received Date: 03/29/2020
• 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: Life Threatening; Other
• Patient Age: 50 YR