InjuryEZX
PYRAMESH C TITANIUM MESH
Received Dec 31, 2009 · Event occurred Dec 8, 2009
Report 1030489-2009-01262 · MDR key 1569851
Device
Product problems
- Explanted
Patient
Not reported
- Unspecified Infection
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PT UNDERWENT A PLIF AT L2-L5 USING INTERBODY DEVICE AND POSTERIOR FIXATION. DUE TO INFECTION AT L4/5, L5 SCREWS AND THE CAGE AT L4/5 WERE REMOVED APPROX ONE MONTH POST OP.
Additional Manufacturer Narrative
NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.