OtherHSH
OPTETRAK
Received Mar 5, 2013
Report 1038671-2013-00013 · MDR key 3001508
Device
Product problems
- Naturally Worn
Patient
Not reported
- Pain
Narrative
Description of Event or Problem
REVISION DUE TO PAIN. SURGEON NOTED WEAR ON INSERT.
Additional Manufacturer Narrative
ENGINEERING EVAL OF RETURNED DEVICES PENDING.