FDA Adverse Event
Injury
Summary report: N
SIGN I.M. NAIL
MDR report key: 1210728
·
Received October 23, 2008
Report
- Report Number
- 3034525-2008-00012
- Event Type
- Injury
- Date Received
- October 23, 2008
- Date of Event
- September 2, 2007
- Report Date
- October 9, 2007
- 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
Additional Manufacturer Narrative · 1
DEVICE MFR DATE: 10/04/2005 OR 01/11/2007.
Description of Event or Problem · 1
I.M. NAIL BROKE DISTALLY SIX MONTHS POST SURGERY WHICH REQUIRED SURGERY TO REPLACE. EVAL OF THE X-RAYS BY DR. ZIRKLE SHOWS A NON-UNION WITH MOTION AT THE FRACTURE SITE.
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) | 80340 | 000124-8-1 OR 000497-19-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Hospitalization| R |