FDA Adverse Event
Injury
Summary report: N
SIGN I.M. NAIL
MDR report key: 1202937
·
Received October 17, 2008
Report
- Report Number
- 3034525-2008-00006
- Event Type
- Injury
- Date Received
- October 17, 2008
- Date of Event
- April 19, 2008
- Report Date
- May 30, 2008
- Manufacturer
- SURGICAL IMPLANT GENERATION NETWORK (SIGN)
- Product Code
- HSB
- PMA / PMN Number
- K022632
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CB
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
FOLLOW UP REPORT OF PT WITH BROKEN SIGN NAIL 2 YEARS AFER INITIAL SURGERY. CAUSE APPEARS TO BE FROM NON-UNION. ADDITIONAL INFO REQUESTED FROM THE HOSP, BUT NONE RECEIVED.
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 | 27 YR | Hospitalization| R |