FDA Adverse Event
Injury
Summary report: N
SIGN I.M. NAIL
MDR report key: 1212655
·
Received October 24, 2008
Report
- Report Number
- 3034525-2008-00023
- Event Type
- Injury
- Date Received
- October 24, 2008
- Date of Event
- November 1, 2006
- Report Date
- November 1, 2006
- Manufacturer
- SURGICAL IMPLANT GENERATION NETWORK (SIGN)
- Product Code
- HSB
- PMA / PMN Number
- K022632
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NP
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
NAIL BROKE DUE TO NON-UNION AND FULL WEIGHT BEARING. A SECOND SURGERY WAS REQUIRED TO REPLACE THE NAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIGN I.M. NAIL | STANDARD I.M. NAIL | HSB | SURGICAL IMPLANT GENERATION NETWORK (SIGN) | 100300 | 000270-8-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Hospitalization| R |