MalfunctionGDG
KMEDIC NERVE HOOK
Received Dec 5, 2016 · Event occurred Nov 14, 2016
Report 6144341 · MDR key 6144341
Device
Product problems
- Break
Patient
47 YR
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) PROCEDURE, ONE OF THE SPINE USA NERVE HOOKS BROKE. THE SURGEON WAS ABLE TO RETRIEVE ALL PIECES. A POST-OPERATIVE X-RAY WAS NEGATIVE FOR RETAINED FOREIGN BODIES.