MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,company representati report with the FDA on 2013-11-19 for XPANDER II EU KX153-C manufactured by Kyphon Neuchatel.
[17953209]
It was reported that a patient underwent an unknown balloon kyphoplasty procedure. During the procedure, it was reported that the balloo ruptured. No further details are known at this time.
Patient Sequence No: 1, Text Type: D, B5
[18073139]
(b)(4): analysis of the returned item shows that during functional analysis, an attempt has been done to inflate the balloon, but it was not possible, because a leak appear under low pressure. Visual analysis confirmed the leakage. A pin hole has been discover on the distal peak of the balloon. Note that under low pressure, only drop comes out from this hole and if the pressure is higher, a water spray is visible. Based on the information provided, functional and visual analysis, the most probable root cause of the leakage is attributed to the contact with bone splinters during surgery.
Patient Sequence No: 1, Text Type: N, H10
[105133834]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2013-00176 |
| MDR Report Key | 3477173 |
| Report Source | 01,05,07,COMPANY REPRESENTATI |
| Date Received | 2013-11-19 |
| Date of Report | 2013-10-22 |
| Date Mfgr Received | 2013-10-22 |
| Date Added to Maude | 2014-01-08 |
| 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 | HUZEFA MAMOOLA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XPANDER II EU |
| Generic Name | CALIBRATOR FOR CELL INDICES |
| Product Code | KRX |
| Date Received | 2013-11-19 |
| Returned To Mfg | 2013-11-01 |
| Catalog Number | KX153-C |
| Lot Number | 0006855134 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KYPHON NEUCHATEL |
| Manufacturer Address | KYPHON SARL PIERRE-A-BOT 97 NEUCHATEL,CH 2000 CH 2000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-19 |