FDA Adverse Event
Injury
Summary report: N
KMI OR KINETIKOS MEDICAL INC
MDR report key: 332362
·
Received February 2, 2001
Report
- Report Number
- 332362
- Event Type
- Injury
- Date Received
- February 2, 2001
- Date of Event
- December 1, 2000
- Report Date
- February 2, 2001
- Manufacturer
- KMI/KINETIKOS MEDICAL INC
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
SPIDER PLATE APPLICATION FOR RIGHT WRIST FUSION OF NON UNION AT ANOTHER HOSP RTO FOR INCREASED PAIN. X-RAY SHOWED 2 BROKEN SCREWS TWENTY DAYS LATER - 3RD SCREW BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 4200 | KMI OR KINETIKOS MEDICAL INC | SPIDER PLATES | HWC | KMI/KINETIKOS MEDICAL INC | 07-24XX | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Hospitalization| R |