FDA Adverse Event
Injury
Summary report: N
SIGN I. M. NAIL
MDR report key: 1882295
·
Received October 20, 2010
Report
- Report Number
- 3034525-2010-00016
- Event Type
- Injury
- Date Received
- October 20, 2010
- Date of Event
- September 30, 2010
- Report Date
- September 30, 2010
- Manufacturer
- SURGICAL IMPLANT GENERATION NETWORK (SIGN)
- Product Code
- HSB
- PMA / PMN Number
- K022632
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AF
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REVIEW OF THE X-RAY SHOWS THE CLEAR CAUSE WAS A SHIFT OF THE NON-UNION FRACTURE SITE WHICH PUT A HIGH AMOUNT OF STRESS ON THE DISTAL END OF THE NAIL AT FULL WEIGHT BEARING. SURGEON REPLACED THE NAIL. 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) | 90380 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Hospitalization |