BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEXUR M

    MDR report key: 2820100 · Received November 1, 2012

    Report

    Report Number
    2246640-2012-00033
    Event Type
    Injury
    Date Received
    November 1, 2012
    Report Date
    October 2, 2012
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MQV
    PMA / PMN Number
    K073405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS MEDWATCH REPORT WAS COMPLETED USING THE INFORMATION PROVIDED BY THE INITIAL REPORTER/HEALTHCARE PROFESSIONAL. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFORMATION NOT HAVING BEEN PROVIDED. WITHOUT ADDITIONAL DEVICE INFORMATION, 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 · 1

    IT WAS REPORTED THAT THE SURGEON USED RESORABLE ALLOGRAFT BONE VOID FILLER DURING A FOOT SURGERY OF UNDETERMINED TYPE, AND THE GRAFT ALLEGEDLY "FAILED." NO ADDITIONAL PATIENT OR DEVICE INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other