James Keith DeOrio - Comment
|
This is a Comment on the Food and Drug Administration (FDA) Notice: Medical Devices; Custom Devices; Request for Comments
For related information,
Open Docket Folder
Comment
To Whom It May Concern:
My names is James K. DeOrio. I am a foot and ankle specialist orthopedic surgeons at Duke University. In this capacity I do approximately 150 ankle replacements yearly. While the vast majority are doing very well there are some unique cases which either because of lack of bone (usually from trauma but occasionally from osteolysis or collapse following ankle replacement) or severe deformity will require a custom prosthesis. This prosthesis will be created strictly for this one patient with this kind of problem. CT scans and plain x-rays will be used to size the prosthesis. The design of the prosthesis will be such that it conforms either to the deformity or to mate with an existing tibial or talar component. If this custom prosthesis cannot be created then it will mean that either the ankle will need to be fused, typically with shortening of the leg. or some compromise will need to be performed that will endanger or excessively remove existing bone. This custom prosthesis will be either a tibial component to match the existing talar component, a talar component to match the existing tibial component or a polyethylene component to match both. Your consideration in allowing us to obtain these custom prosthesis to help patients with severe pain is much appreciated. Thank you
No documents available.
|
|
Comment Period Closed
Jan 18 2013, at 11:59 PM ET
ID:
FDA-2012-N-1045-0007
Tracking Number:
1jx-82vu-n0dj
Submitter Information
Country:
United States
State or Province:
NC
Submitter's Representative:
David Price
Category:
Device Industry - C0012
|