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 2018-12-26 for KYPHON EXPRESS II INFLATABLE BONE TAMP KE102 manufactured by Medtronic Mexico S. De R.l De C.v..
[131423784]
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
[131423805]
It was reported that the patient was pre-operatively diagnosed with compression fracture and underwent balloon kyphoplasty. During the surgery, the balloon did not inflate. The balloon was inserted in the cannula and it ruptured during inflation. There was no hole in the balloon prior to rupture and the balloon ruptured immediately after inflation. The contrast media was leaked. The patient was not allergic to the contrast medium. The product came in contact with the patient. There were no patient complications as a result of event. There was no delay in procedure time as a result of event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2018-03771 |
| MDR Report Key | 8195764 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-26 |
| Date of Report | 2018-12-26 |
| Date of Event | 2018-11-29 |
| Date Mfgr Received | 2018-11-29 |
| Date Added to Maude | 2018-12-26 |
| 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,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 EXPRESS II INFLATABLE BONE TAMP |
| Generic Name | TAMP |
| Product Code | HXG |
| Date Received | 2018-12-26 |
| Model Number | NA |
| Catalog Number | KE102 |
| 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 S. DE R.L DE C.V. |
| Manufacturer Address | AVENIDA PASEO CUCAPAH # 10510 PARQUE INDUSTRIAL EI LAGO TIJUANA,BC 22570 MX 22570 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-26 |