MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-25 for KYPHON XPANDER II INFLATABLE BONE TAMP KX203-C manufactured by Mdt Kyphon Neuchatel Mfg.
[73734981]
The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[73734982]
It was reported that patient underwent balloon kyphoplasty. Intra-op, during the inflation the balloon ruptured. No fragments remained inside the patient. No patient complication were reported for this event.
Patient Sequence No: 1, Text Type: D, B5
[78164392]
Product analysis:during functional analysis it was not more possible to inflate the balloon probably due to a hole or leak on the ibt. During visual analysis, the presence of a radial rupture on the distal peak. Conclusion:based on the information provided, functional and visual analysis the most probable root cause of the rupture of the balloon is attributed to the contact with bone splinters during surgery. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2017-00044 |
| MDR Report Key | 6517690 |
| Date Received | 2017-04-25 |
| Date of Report | 2017-06-01 |
| Date of Event | 2017-03-27 |
| Date Mfgr Received | 2017-06-01 |
| Date Added to Maude | 2017-04-25 |
| 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 | GREG ANGLIN |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MDT KYPHON NEUCHATEL MFG |
| Manufacturer Street | PIERRE- |
| Manufacturer City | NEUCH 2000 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 2000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHON XPANDER II INFLATABLE BONE TAMP |
| Generic Name | TAMP |
| Product Code | HXG |
| Date Received | 2017-04-25 |
| Returned To Mfg | 2017-05-17 |
| Model Number | NA |
| Catalog Number | KX203-C |
| Lot Number | 0008453887 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDT KYPHON NEUCHATEL MFG |
| Manufacturer Address | PIERRE-?-BOT 97 NEUCH?TEL,NE 2000 CH 2000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-25 |