FDA Adverse Event
Other
Summary report: N
9X25MM CALAXO SCREW
MDR report key: 1001448
·
Received February 14, 2008
Report
- Report Number
- 1219602-2008-00027
- Event Type
- Other
- Date Received
- February 14, 2008
- Report Date
- January 2, 2008
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIV.
- Product Code
- HWC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TIBIAL SCREW IS THE ONLY ONE THAT THERE IS AN ISSUE WITH HOWEVER, IT IS UNK IF THIS LOT WAS IMPLANTED IN THE TIBIA AND THEREFORE, THIS INCIDENT IS BEING REPORTED AS A PRECAUTIONARY MEASURE.
Description of Event or Problem · 1
PT WITH A TIBIAL CYST S/P INSERTION OF A CALAXO SCREW. THERE WERE TWO CALAXO SCREWS IMPLANTED, ONE IN THE FEMUR AND ONE IN THE TIBIA. THE TIBIAL SCREW IS THE ONLY ONE THAT HAD AN ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9X25MM CALAXO SCREW | CALAXO SCREW | HWC | SMITH & NEPHEW INC., ENDOSCOPY DIV. | 7211119 | 50203565 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |