MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2009-10-13 for KYPHX INFLATABLE BONE TAMP UNK manufactured by Medtronic Spine Llc..
[1177336]
In an article titled "balloon-related complications and technical failures in kyphoplasty for vertebral fractures" the following events were reported: in the retrospective review conducted at a single center, fifty-one patients were treated by balloon kyphoplasty at 75 spinal levels, and 137 vertebroplasties were also performed. Four of the patients treated with balloon kyphoplasty experienced cortical or endplate fracture by balloon expansion and three of the patients having osteoporosis and one patient having myeloma. In one female patient (with myeloma), the endplate fracture by balloon expansion led to a procedural fracture of an adjacent vertebral body. Additionally, further information reported for the balloon kyphoplasty patients included 5 balloon ruptures, loss of fracture reduction in 4 patients after balloon deflation and transient hyperalgia in 11 patients.
Patient Sequence No: 1, Text Type: D, B5
[8418286]
Report source: article titled: "balloon-related complications and technical failures in kyphoplasty for vertebral fractures", by g. Saliou, d. R. Rutgers, e. M. Kocheida, g. Langman, a. Meurin, h. Deramond, p. Lehmann. Device not returned, internal review of literature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2009-00152 |
| MDR Report Key | 1504658 |
| Report Source | 03 |
| Date Received | 2009-10-13 |
| Date of Report | 2009-09-16 |
| Date of Event | 2009-09-16 |
| Date Mfgr Received | 2009-09-16 |
| Date Added to Maude | 2009-10-19 |
| 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 DIR |
| Manufacturer Street | 1221 CROSSMAN AVE. |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal | 94089 |
| Manufacturer Phone | 4085486500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHX INFLATABLE BONE TAMP |
| Generic Name | INFLATABLE BONE TAMP |
| Product Code | HXG |
| Date Received | 2009-10-13 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SPINE LLC. |
| Manufacturer Address | 1221 CROSSMAN AVE. SUNNYVALE CA 94089 US 94089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-10-13 |