Alphatec Spine, Inc. - March 13, 2015
Issue Date
Mar 13, 2015
Region
Pacific
Category
Device
$117.00
Contact Name
Michael J. Plunkett
Contact Title
Chief Operating Officer
Address 1
5818 El Camino Real
City
Carlsbad
State
CA
Zip/Postal Code
92008
Country
United States
Inspection Range
Feb 04, 2015 - Mar 13, 2015
Pages
6
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): Scott K. Zika