FDA Adverse Event
Other
Summary report: N
KATALYST RADIAL HEAD SYSTEM
MDR report key: 671568
·
Received February 2, 2006
Report
- Report Number
- 2028840-2006-00001
- Event Type
- Other
- Date Received
- February 2, 2006
- Date of Event
- November 1, 2005
- Report Date
- January 30, 2006
- Manufacturer
- KINETIKOS MEDICAL, INC.
- Product Code
- JDC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IN JAN. 2006, KINETIKOS MEDICAL, INC., WAS INFORMED OF THE EXPLANT OF A KATALYST RADIAL HEAD SYSTEM IMPLANT FROM A FEMALE PT IN 2005 OWING TO SPORADIC PAIN. THE EXPLANTED COMPONENTS WERE RETURNED TO KMI FOR EVALUATION IN JANUARY 2006. NO DEFECTS WERE FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KATALYST RADIAL HEAD SYSTEM | ORTHOPAEDIC ELBOW IMPLANT | JDC | KINETIKOS MEDICAL, INC. | 22-12XX | 22-1265/8712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |