BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSTEOSELECT DBM PUTTY

    MDR report key: 3042544 · Received February 19, 2013

    Report

    Report Number
    3005168462-2013-00005
    Event Type
    Other
    Date Received
    February 19, 2013
    Date of Event
    July 12, 2012
    Report Date
    February 19, 2013
    Manufacturer
    BACTERIN INTERNATIONAL INC.
    Product Code
    MQV
    PMA / PMN Number
    K091321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRED TISSUE WAS RETRIEVED AND WAS DISCARDED.

    Description of Event or Problem · 1

    EXPIRED DBM PUTTY WAS INADVERTENTLY DISTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73193 OSTEOSELECT DBM PUTTY DEMINERALIZED BONE MATRIX MQV BACTERIN INTERNATIONAL INC. 2.5CC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA