PLEXUR M
Received Oct 5, 2012
Report 2246640-2012-00025 · MDR key 2780554
Device
Generic name
Resorbable Bone Void Filler
Manufacturer
Osteotech, Inc.Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Unspecified Infection
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PT RECEIVED APPROX 95CC'S OF RESORBABLE BONE VOID FILLER FOLLOWING REMOVAL OF A LARGE TIBIAL BONE TUMOR. THE PT DEVELOPED A POST-OP INFECTION AND THE GRAFT MATERIAL WAS SUBSEQUENTLY EXPLANTED. NO ADD'L PT OR DEVICE INFO WAS PROVIDED.
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. THE SUBJECT PRODUCT IS TERMINALLY STERILIZED WITH GAMMA IRRADIATION PRIOR TO DISTRIBUTION.