FDA Adverse Event
Summary report: N
KYPHX EXPRESS
MDR report key: 1665245
·
Received April 19, 2010
Report
- Report Number
- 1665245
- Date Received
- April 19, 2010
- Date of Event
- January 15, 2010
- Report Date
- April 19, 2010
- Manufacturer
- KYPHON -MEDTRONIC SPINE LLC
- Product Code
- OCJ
- Report Source
- User Facility report
- Reporter Location
- MD, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PATIENT WAS HAVING A KYPHOPLASTY. WHEN THE DILATING BALLOON WAS REMOVED FROM THE SPINE, THERE WAS BLOOD IN IT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================UNSURE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KYPHX EXPRESS | INFLATABLE BONE TAMP | OCJ | KYPHON -MEDTRONIC SPINE LLC | * | 01067751 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |