FDA Adverse Event
Other
Summary report: N
AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM
MDR report key: 6990119
·
Received October 31, 2017
Report
- Report Number
- 1018233-2012-02203
- Event Type
- Other
- Date Received
- October 31, 2017
- Report Date
- December 11, 2012
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- ATTORNEY
- Health Professional
- N
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 771879 | AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM | FTL | SOFRADIM PRODUCTION | NA | ZG100585 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | Required Intervention |