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 2017-09-18 for KYPHON XPANDER II INFLATABLE BONE TAMP KX153-C manufactured by Mdt Kyphon Neuchatel Mfg.
[86585119]
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. Product image review: submitted images appear to display instrument tip puncture. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. 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
[86585120]
It was reported that during the surgery, after the balloon was inserted in the patient through the trocar, the surgeon wanted to dilate the balloon but there was no reaction of the balloon via x-ray to see. So the balloon was put out and checked with water and a hole was noticed at the tip of the balloon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2953769-2017-00097 |
| MDR Report Key | 6871540 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-18 |
| Date of Report | 2017-08-21 |
| Date of Event | 2017-08-19 |
| Date Mfgr Received | 2017-08-21 |
| Date Added to Maude | 2017-09-18 |
| 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 | MDT KYPHON NEUCHATEL MFG |
| Manufacturer Street | PIERRE- |
| Manufacturer City | NEUCH |
| Manufacturer Country | CH |
| 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 | 2017-09-18 |
| Model Number | NA |
| Catalog Number | KX153-C |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDT KYPHON NEUCHATEL MFG |
| Manufacturer Address | PIERRE-?-BOT 97 NEUCH?TEL CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-18 |