OtherHSH
OPTETRAK
Received May 21, 2013 · Event occurred Apr 23, 2013
Report 1038671-2013-00037 · MDR key 3138129
Device
Generic name
Cr Slope Tibial Insert
Manufacturer
Exactech Inc.Product problems
- Insufficient Device Problem Information
Patient
Not reported
- No Code Available
Narrative
Additional Manufacturer Narrative
DEVICE WAS NOT RETURNED TO MFR FOR EVAL. ADDITIONALLY, THE DEVICE IDENTIFICATION NUMBERS WERE NOT PROVIDED PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.
Description of Event or Problem
REVISION OF TIBIAL INSERT. DETAILS OF REVISION WERE NOT PROVIDED TO THE MFR.