FDA Adverse Event
Other
Summary report: N
SLIMFUSE SYSTEM
MDR report key: 1172662
·
Received September 12, 2008
Report
- Report Number
- 1833824-2008-00001
- Event Type
- Other
- Date Received
- September 12, 2008
- Manufacturer
- PIONEER LABORATORIES
- Product Code
- JDN
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ONE SCREW OF A TWO LEVEL CERVICAL CASE WAS TAKEN OUT OF THE PATIENT AFTER IT WAS IDENTIFIED THAT A SCREW HAD BACKED OUT POST OP AND THAT THE PATIENT WAS EXPERIENCING A SENSATION IN HER THROAT WHEN SWALLOWING. THE PATIENT WAS FUSING SO THE SYSTEM WAS LEFT IN WITHOUT A SCREW AT THE LOWER LEVEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SLIMFUSE SYSTEM | CERVICAL PLATING SYSTEM | JDN | PIONEER LABORATORIES | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |