MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-01 for KYPHON XPANDER INFLATABLE BONE TAMP K09A manufactured by Medtronic Mexico S. De R.l De C.v..
[134735964]
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
[134735965]
Type of fracture : compression fracture it was reported that the patient was pre-operatively diagnosed with primary osteoporosis and underwent balloon kyphoplasty at t12. During the surgery, contrast media leaked out from the tip of inflatable bone tamp and balloon did not inflate further. The balloon was inserted in the vertebral body and inflated about 0. 5cc, after that, pressure did not rise when turning the handle. The stylet was not loose. A new product was opened to complete the procedure. The product came in contact with the patient. There was a delay of less than 60 minutes in the overall procedure due to this event. Patient complications were reported to be unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2019-00392 |
| MDR Report Key | 8296129 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-01 |
| Date of Report | 2019-05-20 |
| Date of Event | 2019-01-04 |
| Date Mfgr Received | 2019-05-17 |
| Date Added to Maude | 2019-02-01 |
| 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 S. DE R.L DE C.V. |
| Manufacturer Street | AVENIDA PASEO CUCAPAH # 10510 PARQUE INDUSTRIAL EI LAGO |
| Manufacturer City | TIJUANA,B.C 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 INFLATABLE BONE TAMP |
| Generic Name | TAMP |
| Product Code | HXG |
| Date Received | 2019-02-01 |
| Returned To Mfg | 2019-05-17 |
| Model Number | NA |
| Catalog Number | K09A |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC MEXICO S. DE R.L DE C.V. |
| Manufacturer Address | AVENIDA PASEO CUCAPAH # 10510 PARQUE INDUSTRIAL EI LAGO TIJUANA,B.C 22570 MX 22570 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-01 |