PLEXUR M
Received Oct 5, 2012
Report 2246640-2012-00026 · MDR key 2780569
Device
Generic name
Resorbable Bone Void Filler
Manufacturer
Osteotech, Inc.Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Fluid Discharge
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PT RECEIVED RESORBABLE BONE VOID FILLER IN A SMALL DEFECT OF THE LATERAL DISTAL FEMORAL CONDYLE AND HAD FLUID COLLECTION AT THE GRAFT SITE 3 MONTHS POST-OP. NO ADD'L PT OR DEVICE INFO WAS PROVIDED. IT IS UNK IF ANY ADD'L SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED.
Additional Manufacturer Narrative
THIS MEDWATCH REPORT WAS COMPLETED USING THE INFO PROVIDED BY THE INITIAL REPORTED/HEALTHCARE PROFESSIONAL. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFO NOT HAVING BEEN PROVIDED. WITHOUT ADD'L PT OR DEVICE INFO, NO REVIEW OF THE MFG RECORDS IS POSSIBLE, AND WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.