KYPHON XPEDE BONE CEMENT CX01A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-29 for KYPHON XPEDE BONE CEMENT CX01A manufactured by Medtronic Sofamor Danek Usa, Inc.

Event Text Entries

[186752829] 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.
Patient Sequence No: 1, Text Type: N, H10


[186752830] 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.
Patient Sequence No: 1, Text Type: D, B5


[187798595] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[187798596] The implant date was on or around (b)(4) 2017.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1030489-2020-00395
MDR Report Key9895034
Report SourceCONSUMER
Date Received2020-03-29
Date of Report2020-03-29
Date Mfgr Received2020-03-11
Date Added to Maude2020-03-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTACIE ZIEMBA
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal38132
Manufacturer Phone9013963133
Manufacturer G1MEDTRONIC SOFAMOR DANEK USA, INC
Manufacturer Street4340 SWINEA RD
Manufacturer CityMEMPHIS TN 38118
Manufacturer CountryUS
Manufacturer Postal Code38118
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKYPHON XPEDE BONE CEMENT
Generic NameCEMENT, BONE, VERTEBROPLASTY
Product CodeNDN
Date Received2020-03-29
Model NumberNA
Catalog NumberCX01A
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC SOFAMOR DANEK USA, INC
Manufacturer Address4340 SWINEA RD MEMPHIS TN 38118 US 38118


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Other 2020-03-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.