Theken Spine - July 2, 2010
Issue Date
Jul 02, 2010
Region
Central
Category
Device
$117.00
Address 1
1800 Triplett Blvd.
City
Akron
State
OH
Zip/Postal Code
44306-3311
Country
US
Inspection Range
Jun 14, 2010 - Jul 02, 2010
Pages
5
First Observation
n 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): Michael E. Campbell and Benjamin J. Dastoli