FDA Adverse Event
Injury
Summary report: N
AVAULTA BIOSYNTHETIC SUPPORT SYSTEM- POSTERIOR
MDR report key: 2132652
·
Received April 20, 2011
Report
- Report Number
- 1018233-2011-00080
- Event Type
- Injury
- Date Received
- April 20, 2011
- Report Date
- March 22, 2011
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- NJ, US
- Reporter Occupation
- ATTORNEY
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AVAULTA BIOSYNTHETIC SUPPORT SYSTEM- POSTERIOR | FTL | FTL | SOFRADIM PRODUCTION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention | AVAULTA ANTERIOR SUPPORT SYSTEM |