MalfunctionMBP
OPTECURE ALLOGRAFT, 5CC
Received Nov 12, 2015 · Event occurred Oct 2, 2015
Report 1038671-2015-00659 · MDR key 5220927
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pain
Narrative
Additional Manufacturer Narrative
PENDING ENGINEERING EVALUATION.
Description of Event or Problem
PATIENT CONTACTED EXACTECH VIA E-MAIL COMPLAINING OF PAIN IN HER RIGHT SHOULDER AFTER A RTSR ON (B)(6) 2008.
Additional Manufacturer Narrative
ENGINEERING EVALUATION NOTED THAT THE IDENTIFIED UNIT MET ALL REQUIREMENTS AND WAS ACCEPTABLE FOR TRANSPLANT.
Description of Event or Problem
PATIENT CONTACTED EXACTECH VIA E-MAIL COMPLAINING OF PAIN IN HER RIGHT SHOULDER AFTER A RTSR ON (B)(6) 2008.