InjuryKWQ
OPTERYX CERVICAL PLATE SYSTEM
Received Nov 29, 2010 · Event occurred Sep 15, 2010
Report 3004719693-2010-00001 · MDR key 1908960
Device
Product problems
- Break
Patient
75 YR
- Nonunion/Delayed-union Bone Fracture
Narrative
Description of Event or Problem
REVISION SURGERY--PATIENT DID NOT FUSE. MALE PATIENT IN HIS 70'S--NON-SMOKER. ORIGINAL SURGERY IN (B)(6) 2010 IN (B)(6). REVISION SURGERY (DIFFERENT SURGEON) C5-C7 IN (B)(6) 2010. BOTTOM TWO SCREWS BROKE, CAGES WERE LOOSE, NO FUSION. SURGEON (DR (B)(6)) STATED THAT PROBLEM WAS NOT WITH THE INNOVASIS PRODUCT, BUT WAS CAUSED BY FATIGUE DUE TO NON-FUSION. PATIENT REQUESTED HARDWARE TO TAKE HOME--NOT RETURNED TO INNOVASIS.