FDA Adverse Event
Malfunction
Summary report: N
RADIOLUCENT RIGHT ANGLE DRIVE
MDR report key: 2896466
·
Received November 20, 2012
Report
- Report Number
- 1811755-2012-04126
- Event Type
- Malfunction
- Date Received
- November 20, 2012
- Date of Event
- October 23, 2012
- Report Date
- October 23, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HRX
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
A RADIOLUCENT RIGHT ANGLE DRIVE WAS SENT FOR EVAL BECAUSE DURING TESTING, IT WAS NOTED THAT A SCREW WAS MISSING. THERE WAS NO PT INVOLVEMENT; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIOLUCENT RIGHT ANGLE DRIVE | HRX | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |