FDA Adverse Event
Injury
Summary report: N
GII STANDARD TIBIA B
MDR report key: 3082657
·
Received April 29, 2013
Report
- Report Number
- 8010764-2013-00024
- Event Type
- Injury
- Date Received
- April 29, 2013
- Date of Event
- March 12, 2013
- Report Date
- April 23, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 185779 | GII STANDARD TIBIA B | GNS II CMT TIB SIZE 3 LEFT | JWH | SMITH & NEPHEW, INC. | 09LT36914 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |