FDA Adverse Event
Injury
Summary report: N
SALTO TALARIS
MDR report key: 3133910
·
Received May 23, 2013
Report
- Report Number
- 9610667-2013-00147
- Event Type
- Injury
- Date Received
- May 23, 2013
- Date of Event
- October 15, 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
DELAYED HEALING > 3 WEEKS < 4 WEEKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 229975 | SALTO TALARIS | NONE | HSN | TORNIER SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |