FDA Adverse Event
Injury
Summary report: N
CALLOS
MDR report key: 1934134
·
Received December 21, 2010
Report
- Report Number
- 3025141-2010-00079
- Event Type
- Injury
- Date Received
- December 21, 2010
- Report Date
- November 10, 2010
- Manufacturer
- SKELETAL KINETICS LLC
- Product Code
- MQV
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PHYSICIAN REPORTED WOUND DEHISCENCE IN CALCANEUS FRACTURE REPAIR WHERE CALLOS WAS USED AS BONE VOID FILLER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CALLOS | FILLER, BONE VOID, CALCIUM COMPOUND | MQV | SKELETAL KINETICS LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |