BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSTEOSELECT DBM PUTTY IN A SYRINGE 5.0CC

    MDR report key: 3772478 · Received February 19, 2014

    Report

    Report Number
    3005168462-2014-00001
    Event Type
    Other
    Date Received
    February 19, 2014
    Date of Event
    February 17, 2014
    Report Date
    February 19, 2014
    Manufacturer
    BACTERIN INTERNATIONAL INC.
    Product Code
    MQV
    PMA / PMN Number
    K091321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    EXPIRED OSTEOSELECT DBM PUTTY (PRODUCT ID B120491-725) WAS IMPLANTED ON (B)(6) 2014. THE PRODUCT WAS SHIPPED TO (B)(6) MEDICAL CENTER ON (B)(6) 2013. THE PRODUCT HAD A ONE YEAR EXPIRATION DATE OF 11/28/2013. EXPIRATION DATING FOR THIS PRODUCT FAMILY WAS EXTENDED TO TWO YEARS AS OF APRIL 2013. THEREFORE, THIS PRODUCT WAS ELIGIBLE FOR EXPIRATION DATE EXTENSION TO 11/28/2014. FOR THIS REASON, THERE IS NO RISK TO THE PT ASSOCIATED WITH IMPLANTATION OF THIS PRODUCT. THIS EVENT REPRESENTS FAILURE BY THE INDEPENDENT REPRESENTATIVE TO PROPERLY MANAGE INVENTORY AND AN ERROR BY THE IMPLANTING FACILITY IN NOT VERIFYING THE EXPIRATION DATE PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105203 OSTEOSELECT DBM PUTTY IN A SYRINGE 5.0CC DBM PUTTY MQV BACTERIN INTERNATIONAL INC. NA B120491-DBM

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other GLOBUS SF-FIX CAGE