FDA Adverse Event
Injury
Summary report: N
SIGN I.M. NAIL
MDR report key: 1210727
·
Received October 23, 2008
Report
- Report Number
- 3034525-2008-00011
- Event Type
- Injury
- Date Received
- October 23, 2008
- Date of Event
- August 1, 2007
- Report Date
- August 3, 2007
- Manufacturer
- SURGICAL IMPLANT GENERATION NETWORK (SIGN)
- Product Code
- HSB
- PMA / PMN Number
- K022632
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IMPLANT DATE UNK. DEVICE MFR DATE UNK.
Description of Event or Problem · 1
I.M NAIL BROKE. REQUESTS FOR ADD'L INFO FROM THE HOSP YIELDED NO RESPONSE. REVIEWED THE X-RAYS, BUT THERE IS NOT ENOUGH INFO TO MAKE A REASONABLE DETERMINATION OF THE CAUSE OF THE BREAKAGE.
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) | 100340 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Hospitalization| R |