FDA Adverse Event
Other
Summary report: N
CALAXO - UNK
MDR report key: 1010137
·
Received March 10, 2008
Report
- Report Number
- 1219602-2008-00050
- Event Type
- Other
- Date Received
- March 10, 2008
- Report Date
- February 7, 2008
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIV.
- Product Code
- HWC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PROD RECALL INITIATED AUGUST 21, 2007.
Description of Event or Problem · 1
THE MALE PT UNDERWENT ACL RECONSTRUCTION PROCEDURE WITH THE USE CALAXO SCREW INSERTED IN THE TIBIA APPROX A YR AGO. THE PT NOW PRESENTS POST-OP INFLAMMATORY REACTION WITH PRE-TIBIAL SWELLING AND HAD A SYNOVECTOMY PROCEDURE AND HAVE ANTIBIOTICS INITIALLY FOR ONE MONTH. THE PT WAS DEBRIDED AND THE GRAFT LOOKS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CALAXO - UNK | CALAXO SCREW | HWC | SMITH & NEPHEW INC., ENDOSCOPY DIV. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |