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 2017-06-13 for KYPHON EXPRESS INFLATABLE BONE TAMP KE152 manufactured by Mdt Kyphon Neuchatel Mfg.
[77447211]
Product analysis : the center shaft of the ibt where the markers are located has collapsed and is folded inside the balloon tip. The balloon is also leaking where the center shaft passes through and is glued to the balloon. The ibt appears to have been inflated, it is unknown at this time if the balloon arrived damaged or if it became damaged during use. The stylet is bent. 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
[77447212]
It was reported that patient with osteoporosis and vertebral compression fracture underwent balloon kyphoplasty at t8/9. Intra-op, the two radiopaque markers were too close and the inflation of the balloon was irregular. The inflatable bone tamp (ibt) failed during the first insertion attempt into the vertebral body. The surgery was completed successfully with the original product. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[105926366]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2017-00072 |
| MDR Report Key | 6636008 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-06-13 |
| Date of Report | 2017-05-30 |
| Date of Event | 2017-03-03 |
| Date Mfgr Received | 2017-05-30 |
| Date Added to Maude | 2017-06-13 |
| 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 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 EXPRESS INFLATABLE BONE TAMP |
| Generic Name | TAMP |
| Product Code | HXG |
| Date Received | 2017-06-13 |
| Returned To Mfg | 2017-03-13 |
| Model Number | NA |
| Catalog Number | KE152 |
| Lot Number | 0008228442 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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,NE 2000 CH 2000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-13 |