OtherHSH
OPTETRAK KNEE COMPONENTS
Received Oct 17, 2012 · Event occurred Jul 1, 2012
Report 1038671-2012-00128 · MDR key 2818415
Device
Generic name
None
Manufacturer
Exactech, Inc.Product problems
- Insufficient Device Problem Information
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
REVISION OF OPTETRAK COMPONENTS. THE REASON FOR REVISION WAS NOT REPORTED. THIS EVENT OCCURRED OUTSIDE OF THE U.S, IN (B)(6).
Additional Manufacturer Narrative
THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVAL. ADDITIONALLY, THE DEVICE CATALOG AND SERIAL NUMBERS WERE NOT REPORTED PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.