Ortho Solutions dba DynaFlex - Sept. 26, 2019
Issue Date
Sep 26, 2019
Region
Southwest
Category
Device
$117.00
Contact Name
Darren G. Buddemeyer
Contact Title
CEO
Address 1
10403 International Plaza Dr.
City
Saint Ann
State
MO
Zip/Postal Code
63074-1805
Country
United States
Inspection Range
Aug 26, 2019 - Sep 05, 2019
Pages
7
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): Edward E. Lockwood