FDA Adverse Event
Injury
Summary report: N
SALTO TALARIS
MDR report key: 3133929
·
Received May 23, 2013
Report
- Report Number
- 9610667-2013-00146
- Event Type
- Injury
- Date Received
- May 23, 2013
- Date of Event
- February 28, 2007
- Report Date
- March 26, 2013
- Manufacturer
- TORNIER SAS
- Product Code
- HSN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.
Description of Event or Problem · 1
NUMBNESS - POST OP NERVE INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 229670 | SALTO TALARIS | NONE | HSN | TORNIER SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |