BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSTEOSELECT DBM PUTTY

    MDR report key: 3035992 · Received March 15, 2013

    Report

    Report Number
    3005168462-2013-00004
    Event Type
    Other
    Date Received
    March 15, 2013
    Date of Event
    April 16, 2012
    Report Date
    February 19, 2013
    Manufacturer
    BACTERIN INTERNATIONAL, INC.
    Product Code
    MQV
    PMA / PMN Number
    K091321
    Removal / Correction Number
    Z-0800-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRED TISSUE WAS DISTRIBUTED BUT RETRIEVED PRIOR TO IMPLANTATION. THE AFFECTED PRODUCT WAS DESTROYED.

    Description of Event or Problem · 1

    EXPIRED DBM PUTTY WAS INADVERTENTLY DISTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110403 OSTEOSELECT DBM PUTTY DEMINERALIZED BONE MATRIX MQV BACTERIN INTERNATIONAL, INC. 2.5CC B090056-DBM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA