Surgical Design, Inc. - July 29, 2013
Issue Date
Jul 29, 2013
Region
Southeast
Category
Device
$117.00
Contact Name
Mohammad (NMI) Bashir
Contact Title
President
Address 1
7351 Lockport Pl.
Address 2
Suite D
City
Lorton
State
VA
Zip/Postal Code
22079-1571
Country
United States
Inspection Range
Jun 04, 2013 - Jun 18, 2013
Pages
5
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): Andrew A. Leboeuf