Omni Surgical, L.P. dba Spine 360 - March 29, 2010
Issue Date
Mar 29, 2010
Region
Southwest
Category
Device
$117.00
Address 1
5000 Plaza on the Lake
Address 2
Suite 305
City
Austin
State
TX
Zip/Postal Code
78746
Country
US
Inspection Range
Mar 23, 2010 - Mar 29, 2010
Pages
2
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): Jennifer Hua and Iris C. Macinnes