FDA Adverse Event
Injury
Summary report: N
SIGN I. M. NAIL
MDR report key: 2202348
·
Received August 5, 2011
Report
- Report Number
- 3034525-2011-00032
- Event Type
- Injury
- Date Received
- August 5, 2011
- Date of Event
- July 23, 2011
- Report Date
- August 1, 2011
- Manufacturer
- SURGICAL IMPLANT GENERATION NETWORK (SIGN)
- Product Code
- HSB
- PMA / PMN Number
- K022632
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NI
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DATABASE REPORT OF BROKEN I. M NAIL DUE TO SECONDARY ACCIDENT (A FALL) BY THE PT. WHEN THE PT CAME IN FOR FOLLOW UP, THE SURGEON FOUND THE IMPLANTED NAIL WAS BROKEN AT THE FRACTURE SITE WHICH HAD A NONUNION. CAUSE PT FELL WHILE FULL WEIGHTBEARING ON A NONUNION. 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) | 90420 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Hospitalization |