BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBM PUTTY 5.0CC, AXOGRAFT

    MDR report key: 6866780 · Received September 14, 2017

    Report

    Report Number
    3005168462-2017-00002
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Date of Event
    August 17, 2017
    Report Date
    September 11, 2017
    Manufacturer
    BACTERIN INTERNATIONAL, INC.
    Product Code
    MBP
    UDI-DI
    00849777005661
    PMA / PMN Number
    K130498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT CONDITION WAS AGAIN VERIFIED ON 09/11/2017 (DATE OF THIS REPORT) AND NO COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ON (B)(4) 2017 BACTERIN WAS NOTIFIED OF AN EXPIRED DBM PUTTY GRAFT IMPLANT. THE GRAFT WAS SOLD AND DISTRIBUTED TO A PRIVATE LABEL DISTRIBUTOR ON 11/02/2015. THE PRIVATE LABEL DISTRIBUTOR SHIPPED THE GRAFT TO THE END-USER FACILITY ON 11/23/2015. THE GRAFT EXPIRED ON 12/03/2016, AND THEN WAS IMPLANTED ON (B)(6) 2017. AT THE TIME OF THIS REPORT THERE WERE NO KNOWN COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646979 DBM PUTTY 5.0CC, AXOGRAFT FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) MBP BACTERIN INTERNATIONAL, INC. X090-0015-PT5CC B110137-DBM 00849777005661

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR