FDA Adverse Event
Other
Summary report: N
1222081-2008-00018
MDR report key: 1131604
·
Received August 9, 2008
Report
- Report Number
- 1222081-2008-00018
- Event Type
- Other
- Date Received
- August 9, 2008
- Product Code
- HTT
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SHOWS SCORING ON THE INTERNAL SHAFT. SHAFT DOES NOT APPEAER TO BE BENT, AND THERE ARE NO IRREGULARITIES SHOWING ON THE DISTAL TIP. BASED ON EVAL, THERE WAS NO MALFUNCTION OF THE BURR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HTT | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |