MalfunctionMNI
NUVASIVE
Received Nov 7, 2012 · Event occurred Aug 21, 2012
Report MW5027573 · MDR key 2830327
Device
Generic name
Nuvasive Maxcess Docking Screw
Manufacturer
Nuvasive IncModel number
NUVASIVE MAXCESSLot number
121287
Product problems
- Break
- Detachment Of Device Component
Patient
49 YR
- Foreign Body In Patient
Narrative
Description of Event or Problem
THE PT UNDERWENT ELECTIVE LUMBAR SPINE FUSION ON (B)(6) 2012. DURING THE PROCEDURE, THE TIPS OF TWO ANCHOR SCREWS BROKE OFF INSIDE THE L2 AND L3 VERTEBRAE. THE SURGEON ELECTED TO LEAVE THEM IN BECAUSE THEY POSED NO DANGER TO THE PT, AND RETRIEVAL WOULD HAVE INCREASED THE RISK OF HARM.