PLEXUR M
Received Oct 17, 2012 · Event occurred Jul 1, 2012
Report 2246640-2012-00030 · MDR key 2799629
Device
Generic name
Resorbable Bone Void Filler
Manufacturer
Osteotech, Inc.Product problems
- Extrusion
Patient
Not reported
- Inflammation
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SURGEON USED RESORBABLE ALLOGRAFT BONE VOID FILLER TO FILL A DISTAL FEMUR DEFECT. APPROX 6-8 WEEKS POST OP, THE PT'S INCISION SITE SHOWED GRITTY MATERIAL COMING OUT AND INFLAMMATION. SURGEON DID NOT REMOVE ANY GRAFT MATERIAL, FLUSH THE SITE OR RE-GRAFT. NO ADD'L INFO WAS PROVIDED.
Additional Manufacturer Narrative
THIS MEDWATCH REPORT WAS COMPLETED USING THE INFO PROVIDED BY THE INITIAL REPORTER/HEALTHCARE PROFESSIONAL. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFO NOT HAVING BEEN PROVIDED. WITHOUT ADD'L DEVICE INFO, NO REVIEW OF THE DEVICE HISTORY RECORD WAS POSSIBLE, AND WE ARE UNABLE TO DETERMINE A DEFINITIVE CAUSE OF THE REPORTED EVENT.