MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-08-21 for KYPHON XPANDER II INFLATABLE BONE TAMP KX203 manufactured by Medtronic Mexico (tijuana).
[117744571]
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
[117744572]
It was reported that the patient underwent balloon kyphoplasty due to vertebral compression fracture at l1. Intra-op, the balloon ruptured on the right side of l1. The balloon was deflated successfully. Blood began pulsating out of the right cannula. Then, balloon on left was deflated and inserted into the right cannula and inflated. Now, blood began pulsating out of left cannula as well. The surgeon decided to inject surgiflow down both cannulas. Bleeding stopped at this time. Both the balloons were inflated once more. Finally, about 7. 5 cc of cement was injected into l1 successfully. A 300 ml of blood was lost due to this event. Ct conducted after the surgery revealed a small psoas hematoma. The patient is stable and is recovering from hematoma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2018-02110 |
| MDR Report Key | 7801504 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-21 |
| Date of Report | 2018-08-21 |
| Date of Event | 2018-07-26 |
| Date Mfgr Received | 2018-07-26 |
| Date Added to Maude | 2018-08-21 |
| 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 MEXICO (TIJUANA) |
| Manufacturer Street | AVENIDA PASEO CUCAPAH # 10510 PARQUE INDUSTRIAL EI LAGO |
| Manufacturer City | TIJUANA,BC 22570 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22570 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHON XPANDER II INFLATABLE BONE TAMP |
| Generic Name | ARTHROSCOPE |
| Product Code | HXG |
| Date Received | 2018-08-21 |
| Model Number | NA |
| Catalog Number | KX203 |
| 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 MEXICO (TIJUANA) |
| Manufacturer Address | AVENIDA PASEO CUCAPAH # 10510 PARQUE INDUSTRIAL EI LAGO TIJUANA,BC 22570 MX 22570 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-21 |