FDA Adverse Event
Injury
Summary report: N
KALIX II FLAT FOOT IMPLANT EXTERNAL DIAM. 11MM
MDR report key: 2166385
·
Received May 22, 2007
Report
- Report Number
- 9615741-2007-00027
- Event Type
- Injury
- Date Received
- May 22, 2007
- Date of Event
- April 17, 2007
- Report Date
- May 22, 2007
- Manufacturer
- NEWDEAL S.A.
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
THE DISTRIBUTOR REPORTED ON BEHALF OF THE USER FACILITY THE FOLLOWING INCIDENT: THE SURGERY, THE PHYSICIAN ATTEMPTED TO INSERT A KALIX II IMPLANT SIZE 11. THE IMPLANT DID NOT EXPAND. THE IMPLANT WAS REMOVED AND IS AVAILABLE FOR EVALUATION. A KALIX II IMPLANT SIZE 10 WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURY OCCURRED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE USER FACILITY. THIS INCIDENT IS RELATED TO MDR# 9615741-2007-00026.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KALIX II FLAT FOOT IMPLANT EXTERNAL DIAM. 11MM | KALIX II SYSTEM | HWC | NEWDEAL S.A. | E3FE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |