FDA Adverse Event
Other
Summary report: N
SYNTHES 400.835
MDR report key: 692125
·
Received March 6, 2006
Report
- Report Number
- 692125
- Event Type
- Other
- Date Received
- March 6, 2006
- Date of Event
- February 9, 2006
- Report Date
- March 6, 2006
- Manufacturer
- SYNTHES USA, INC.
- Product Code
- HWC
- Report Source
- User Facility report
- Reporter Location
- VA, US
Narratives
Description of Event or Problem · 1
DURING THE PLACEMENT OF SYNTHES MAXILLO-FACIAL SELF DRILLING SCREWS INTO THE BURR HOLE COVERS, FOUR SCREW HEADS BROKE OFF. THE SHAFT OF THE SCREWS WERE RETAINED IN THE BONE AND IT COULD NOT BE REMOVED. THE SCREWS THAT BROKE WERE FIVE MILLIMETERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNTHES 400.835 | HARDWARE SYSTEM, MANDIBLE | HWC | SYNTHES USA, INC. | SCREW 5MM /SELF DRILLING | 1 29 3/29JAN2006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR |