PLEXUR M
Received Oct 17, 2012 · Event occurred Sep 1, 2012
Report 2246640-2012-00029 · MDR key 2799641
Device
Generic name
Resorbable Bone Void Filler
Manufacturer
Osteotech, Inc.Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Erythema
- Discharge
Narrative
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.
Description of Event or Problem
IT WAS REPORTED THAT THE SURGEON USED RESORBABLE ALLOGRAFT BONE VOID FILLER TO FILL A LARGE BENIGN BONE CYST IN THE PT'S DISTAL FEMUR. APPROX 14 WEEKS POST-OP, THE PT'S MOTHER CONTACTED THE SURGEON TO REPORT THAT THE WOUND APPEARED RED AND ANGRY LOOKING. IN THE OFFICE THE SURGEON FOUND THAT THE INCISION HAD BROKEN DOWN AND GRITTY MATERIAL COMING OUT OF THE INCISION. HE DID NOT REMOVE ANY GRAFT MATERIAL, FLUSH THE SITE OR RE-GRAFT. SURGEON TOOK A SAMPLE OF THE MATERIAL AND LIQUID FROM THE INCISION SITE.