FDA Adverse Event
Injury
Summary report: N
INTERTAN
MDR report key: 4190416
·
Received October 21, 2014
Report
- Report Number
- 1020279-2014-00656
- Event Type
- Injury
- Date Received
- October 21, 2014
- Date of Event
- August 29, 2014
- Report Date
- October 6, 2014
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 667404 | INTERTAN | BONE SCREW | HWC | SMITH & NEPHEW, INC. | OR71642250 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Hospitalization| R |