BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEXUR M

    MDR report key: 2780554 · Received October 5, 2012

    Report

    Report Number
    2246640-2012-00025
    Event Type
    Injury
    Date Received
    October 5, 2012
    Report Date
    September 12, 2012
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MBP
    PMA / PMN Number
    K081227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEXUR M RESORBABLE BONE VOID FILLER MBP OSTEOTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other