FDA Adverse Event
Other
Summary report: N
SUBTALAR MBA SYSTEM
MDR report key: 529909
·
Received June 7, 2004
Report
- Report Number
- 2028840-2004-00021
- Event Type
- Other
- Date Received
- June 7, 2004
- Date of Event
- June 1, 2004
- Report Date
- June 1, 2004
- Manufacturer
- KINETIKOS MEDICAL INC.
- Product Code
- HWC
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IN 2004, KINETIKOS MEDICAL, INC., WAS INFORMED OF THE EXPLANT OF A 9MM SUBTALAR MBA ORTHOPEDIC FOOT IMPLANT TO ADDRESS PAIN IN THE SUBTALAR REGION. THE DEVICE WAS RETURNED TO KMI FOR INVESTIGATION. NO DEVICE DEFECTS WERE DISCOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUBTALAR MBA SYSTEM | ORTHOPEDIC FOOT IMPLANT | HWC | KINETIKOS MEDICAL INC. | 05-0109 | 8342 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |