MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-09-24 for KYPHX XPANDER INFLATABLE BONE TAMP 10/3 K13A manufactured by Medtronic Spine Llc..
[17727885]
During a two level balloon kyphoplasty procedure at levels t4 and t5, it was reported that the balloon ruptured. The treating physician attempted to remove the fragments of the balloon but was unsuccessful. Bone cement extravasation was noted following delivery of cement to the vertebral bodies. The balloon fragments remained in the vertebral body entombed in bone cement. The pt experienced sensory and strength deficits immediately post-operation due to extravasation of bone cement. The treating physician and neurosurgeon decided to treat the deficits with physical rehabilitation. At this time, pt continues to have some sensory loss and muscle weakness.
Patient Sequence No: 1, Text Type: D, B5
[17984758]
Method: device not returned, follow up conversation with company rep.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2008-00044 |
| MDR Report Key | 1174179 |
| Report Source | 05,07 |
| Date Received | 2008-09-24 |
| Date of Report | 2008-08-27 |
| Date of Event | 2008-08-26 |
| Date Mfgr Received | 2008-08-27 |
| Date Added to Maude | 2008-09-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | PAMELA SEGALE, SR. DIRECTOR |
| Manufacturer Street | 1221 CROSSMAN AVE. |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal | 94089 |
| Manufacturer Phone | 4085485235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHX XPANDER INFLATABLE BONE TAMP 10/3 |
| Generic Name | INFLATABLE BONE TAMP |
| Product Code | HXG |
| Date Received | 2008-09-24 |
| Model Number | NA |
| Catalog Number | K13A |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1205477 |
| Manufacturer | MEDTRONIC SPINE LLC. |
| Manufacturer Address | 1221 CROSSMAN AVE. SUNNYVALE CA 94089 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-09-24 |