FDA Adverse Event
Injury
Summary report: N
SUBTALAR M.B.A.
MDR report key: 510292
·
Received February 4, 2004
Report
- Report Number
- 2028840-2004-00006
- Event Type
- Injury
- Date Received
- February 4, 2004
- Date of Event
- January 26, 2004
- Report Date
- February 4, 2004
- Manufacturer
- KINETIKOS MEDICAL, INC.
- Product Code
- ISH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON FEB. 04, 2003, K.M.I. WAS NOTIFIED OF THE EXPLANT OF A 9MM MBA 10 MONTHS AFTER ITS ORIGINAL IMPLANT DATE TO ADDRESS PAIN REPORTED BY THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUBTALAR M.B.A. | ORTHOPAEDIC FOOT IMPLANT | ISH | KINETIKOS MEDICAL, INC. | 05-0109 | 7773-9-7956 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other |