FDA Adverse Event
Other
Summary report: N
KYPHX INFLATABLE BONE TAMP
MDR report key: 293552
·
Received August 24, 2000
Report
- Report Number
- 2953769-2000-00004
- Event Type
- Other
- Date Received
- August 24, 2000
- Date of Event
- July 3, 2000
- Report Date
- August 23, 2000
- Manufacturer
- KYPHON INC.
- Product Code
- HXG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT WITH A 3 MONTH OLD T12 FRACTURE UNDERWENT FRACTURE REDUCTION AND FIXATION. THE PT AWOKE WITH AN ILEUS THE NEXT MORNING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KYPHX INFLATABLE BONE TAMP | BONE TAMP | HXG | KYPHON INC. | NA | 09650200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |