FDA Adverse Event
Injury
Summary report: N
HINDFOOT FUSION NAIL
MDR report key: 2920342
·
Received January 17, 2013
Report
- Report Number
- 1020279-2013-00030
- Event Type
- Injury
- Date Received
- January 17, 2013
- Report Date
- January 15, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MDR 1020279-2013-00030 REPORT FILED IN ERROR, NO REVISION SURGERY WAS PERFORMED.
Description of Event or Problem · 1
MDR 1020279-2013-00030 REPORT FILED IN ERROR, NO REVISION SURGERY WAS PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26467 | HINDFOOT FUSION NAIL | HFN 11.5MMX20CM RIGHT | JDS | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | (B)(4) INT HEX CAP SCR 5.0MM X 35MM| (B)(4) INT HEX CAP SCR 5.0MM X 95MM| (B)(4) INT HEX CAP SCR 5.0MM X 45MM| (B)(4) INT HEX CAP SCR 5.0MM X 85MM |