FDA Adverse Event
Injury
Summary report: N
SUBTALAR M.B.A.
MDR report key: 441715
·
Received February 4, 2003
Report
- Report Number
- 2028840-2003-00007
- Event Type
- Injury
- Date Received
- February 4, 2003
- Date of Event
- January 22, 2003
- Manufacturer
- KINETIKOS MEDICAL, INC.
- Product Code
- HRS
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON FEBRUARY 3, 2003, KINETIKOS MEDICAL, INC., WAS INFORMED THAT AN EXPLANT OF A SUBTALAR MBA HAD BEEN PERFORMED IN 2003. THE EXPLANT WAS PERFORMED AT THE DISCRETION OF THE ATTENDING PHYSICIAN AT THE PT'S REQUEST TO ADDRESS PAIN. THE ORIGINAL IMPLANT SURGERY DATE WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUBTALAR M.B.A. | ORTHOPAEDIC FOOT IMPLANT | HRS | KINETIKOS MEDICAL, INC. | O5-01XX | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |