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 CX01B manufactured by Medtronic Sofamor Danek Usa, Inc.
[186752720]
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
[186752721]
It was reported that on or around (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
| Report Number | 1030489-2020-00396 |
| MDR Report Key | 9895036 |
| Report Source | CONSUMER |
| Date Received | 2020-03-29 |
| Date of Report | 2020-03-29 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACIE ZIEMBA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Street | 4340 SWINEA RD |
| Manufacturer City | MEMPHIS TN 38118 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38118 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHON XPEDE BONE CEMENT |
| Product Code | NDN |
| Date Received | 2020-03-29 |
| Model Number | NA |
| Catalog Number | CX01B |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2020-03-29 |