MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-23 for KYPHON EXPRESS INFLATABLE BONE TAMP KE202 manufactured by Kyphon / Medtronic.
[61087548]
Rt kyphon balloon used during kyphoplasty. Right balloon ruptured inside the pt's vertebrae. Unable to retrieve the balloon through the cannula and piece of balloon left behind in vertebrae.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066334 |
| MDR Report Key | 6128641 |
| Date Received | 2016-11-23 |
| Date of Report | 2016-11-23 |
| Date of Event | 2016-11-22 |
| Date Added to Maude | 2016-11-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KYPHON EXPRESS INFLATABLE BONE TAMP |
| Generic Name | INFLATABLE BONE TAMP |
| Product Code | HXG |
| Date Received | 2016-11-23 |
| Model Number | KE202 |
| Lot Number | 0007638668 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KYPHON / MEDTRONIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-23 |