BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOSELECT

    MDR report key: 6421696 · Received March 21, 2017

    Report

    Report Number
    3005168462-2017-00001
    Event Type
    Malfunction
    Date Received
    March 21, 2017
    Date of Event
    February 23, 2017
    Report Date
    March 20, 2017
    Manufacturer
    BACTERIN INTERNATIONAL, INC.
    Product Code
    MBP
    UDI-DI
    00849777003681
    PMA / PMN Number
    K130498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY WAS NOTIFIED ON 02/24/2017 THAT AN EXPIRED PRODUCT WAS IMPLANTED INTO A PATIENT ON (B)(6) 2017. THE PRODUCT'S EXPIRATION DATE WAS 02/08/2017. THE HOSPITAL WAS NOTIFIED BY THE COMPANY ON 02/20/2017 THAT THEY HAD AN EXPIRED GRAFT IN INVENTORY. SUBSEQUENT COMMUNICATION WITH THE HOSPITAL ON 03/10/2017, REVEALED THAT AN EMPLOYEE ABSENCE COULD HAVE CONTRIBUTED TO THE INCIDENT DESPITE THE NOTIFICATION FROM THE COMPANY. PATIENT DISCHARGED ON (B)(6) 2017 WITH NO KNOWN COMPLICATIONS. DEVICE IMPLANTED, NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE COMPANY WAS NOTIFIED ON 02/24/2017 THAT AN EXPIRED PRODUCT WAS IMPLANTED INTO A PATIENT ON (B)(6) 2017. THE PRODUCT'S EXPIRATION DATE WAS 02/08/2017. THE HOSPITAL WAS NOTIFIED BY THE COMPANY ON 02/20/2017 THAT THEY HAD AN EXPIRED GRAFT IN INVENTORY. SUBSEQUENT COMMUNICATION WITH THE HOSPITAL ON 03/10/2017, REVEALED THAT AN EMPLOYEE ABSENCE COULD HAVE CONTRIBUTED TO THE INCIDENT DESPITE THE NOTIFICATION FROM THE COMPANY. PATIENT DISCHARGED ON (B)(6) 2017 WITH NO KNOWN COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202387 OSTEOSELECT FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) MBP BACTERIN INTERNATIONAL, INC. 359100 B110246-DBM 00849777003681

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR