FDA Adverse Event
Injury
Summary report: N
SIGN I.M. NAIL
MDR report key: 2232607
·
Received August 25, 2011
Report
- Report Number
- 3034525-2011-00034
- Event Type
- Injury
- Date Received
- August 25, 2011
- Date of Event
- August 14, 2011
- Report Date
- August 25, 2011
- Manufacturer
- SURGICAL IMPLANT GENERATION NETWORK (SIGN)
- Product Code
- HSB
- PMA / PMN Number
- K022632
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UG
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EXCHANGE NAIL SURGERY REQUIRED TO REPLACE BENT I.M. NAIL FOUND AT FOLLOW UP. CAUSE: POSSIBLE FALL OR ACCIDENT. 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) | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Hospitalization |