Ideal Implant Inc. - Feb. 3, 2016
Issue Date
Feb 03, 2016
Region
Southwest
Category
Device
$117.00
Contact Name
Denise Wrestler
Contact Title
Quality Assurance Manager
Address 1
5005 Lyndon B. Johnson Fwy.
Address 2
Ste. 900
City
Dallas
State
TX
Zip/Postal Code
75244-6100
Country
United States
Inspection Range
Feb 01, 2016 - Feb 03, 2016
Pages
3
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Iris C. Macinnes