FDA Adverse Event
Injury
Summary report: N
SIGN SERIES IV STEP SCREW
MDR report key: 1982275
·
Received February 1, 2011
Report
- Report Number
- 3034525-2011-00009
- Event Type
- Injury
- Date Received
- February 1, 2011
- Date of Event
- May 20, 2010
- Report Date
- January 31, 2011
- Manufacturer
- SURGICAL IMPLANT GENERATION NETWORK (SIGN)
- Product Code
- HSB
- PMA / PMN Number
- K022632
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SL
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
SERIES IV STEP SCREW WAS FOUND TO BE BROKEN AT TIME OF FOLLOW UP. HOWEVER, SURGERY WAS TO EXCHANGE I.M. NAIL DUE TO DEEP INFECTION (OSTEOMYELITIS). THE BROKEN SCREW WAS ALSO REPLACED. NO PRODUCT DEFECT INDICATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIGN SERIES IV STEP SCREW | INTERLOCKING SCREW | HSB | SURGICAL IMPLANT GENERATION NETWORK (SIGN) | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Hospitalization |