FDA Adverse Event
Injury
Summary report: N
SIGN I. M. NAIL
MDR report key: 2243836
·
Received September 7, 2011
Report
- Report Number
- 3034525-2011-00035
- Event Type
- Injury
- Date Received
- September 7, 2011
- Date of Event
- August 26, 2011
- Report Date
- September 6, 2011
- Manufacturer
- SURGICAL IMPLANT GENERATION NETWORK (SIGN)
- Product Code
- HSB
- PMA / PMN Number
- K022632
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RP
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DATABASE REPORT OF BROKEN SIGN NAIL. CAUSE OF THE BREAKAGE WAS THAT THE PATIENT TOOK A FALL ON A LONG STANDING NONUNION. THIS CAUSED A NEW FRACTURE AT THE SITE OF THE NONUNION. NO INDICATION OF PRODUCT DEFECT.
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) | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Hospitalization |