FDA Adverse Event
Injury
Summary report: N
BLACKSTONE ICON SPINAL FIXATION SYSTEM
MDR report key: 1013319
·
Received March 12, 2008
Report
- Report Number
- 1225457-2008-00004
- Event Type
- Injury
- Date Received
- March 12, 2008
- Date of Event
- February 27, 2008
- Report Date
- March 7, 2008
- Manufacturer
- BLACKSTONE MEDICAL, INC.
- Product Code
- KWQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
L5 SCREW/SETSCREW LOOSENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BLACKSTONE ICON SPINAL FIXATION SYSTEM | SET SCREW | KWQ | BLACKSTONE MEDICAL, INC. | 54-2001 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |