OtherHTG
OPTETRAK
Received Aug 1, 2012 · Event occurred Feb 13, 2012
Report 1038671-2012-00108 · MDR key 2703769
Device
Product problems
- Device Slipped
Patient
Not reported
- No Code Available
Narrative
Additional Manufacturer Narrative
THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD PROVIDES ASSURANCE THE PART WAS ACCEPTED WITH CONFORMANCE TO THE PRODUCT REQUIREMENTS.
Description of Event or Problem
REVISION OF OPTETRAK COMPONENTS DUE TO TIBIAL SUBSIDENCE. THIS EVENT OCCURRED IN (B)(6).