PLEXUR M
Received Oct 5, 2012
Report 2246640-2012-00028 · MDR key 2780570
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
A MEDTRONIC EMPLOYEE OVERHEARD THAT A PT WHO HAD RECEIVED RESORBABLE BEEN VOID FILLER IN A TIBIAL PLATEAU PROCEDURE DEVELOPED A POST-OP INFECTION. IT IS UNK IF ANY ADD'L SURGICAL INTERVENTION WAS REQUIRED. ALL ATTEMPTS TO OBTAIN ADD'L PT AND DEVICE INFO HAVE NOT BEEN SUCCESSFUL.
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 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.