FDA Adverse Event
Malfunction
Summary report: N
EBI DYNAFIX CORTICAL SCREW
MDR report key: 776371
·
Received August 24, 2006
Report
- Report Number
- 2242816-2006-00030
- Event Type
- Malfunction
- Date Received
- August 24, 2006
- Date of Event
- July 14, 2006
- Report Date
- August 18, 2006
- Manufacturer
- EBI, L.P.
- Product Code
- NDF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
SCREWS BECAME STUCK IN PATIENT'S INCISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EBI DYNAFIX CORTICAL SCREW | NDF | NDF | EBI, L.P. | * | 336101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |