BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOWRAP

    MDR report key: 16663195 · Received April 3, 2023

    Report

    Report Number
    16663195
    Event Type
    Malfunction
    Date Received
    April 3, 2023
    Date of Event
    April 4, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BACTERIN INTERNATIONAL, INC.
    Product Code
    MBP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PATIENT ENTERED THE OPERATING ROOM (OR) FOR SURGERY. THE REPRESENTATIVE CAME, BRINGING THE ALLOGRAFT PACKAGES, REMOVED THE ALLOGRAFT IMPLANTS FROM THE BOX AND GAVE THE CONTENTS TO THE OR REGISTERED NURSE (RN). NO PROBLEM WITH STERILE PACKAGING. IMPLANTS WERE USED. LATER WHEN FILLING OUT THE PATIENT HUMAN TISSUE IMPLANT RECORD IT WAS DISCOVERED THAT THE BACTERIN PAPERWORK HAD ALREADY BEEN FILLED IN WITH ANOTHER PATIENT'S INFORMATION. APPARENTLY THE TISSUE TRACKING FORM HAD BEEN FILLED OUT BY A SALES REPRESENTATIVE BUT THE TISSUE HAD NOT BEEN IMPLANTED. THE REPRESENTATIVE NOTIFIED THE COMPANY WHO TOLD HIM THAT IT IS NOT UNCOMMON TO RECEIVE UNUSED PRODUCT AND RETURN IT TO THEIR SHELVES FOR REDISTRIBUTION. THE BOX HAD NO SEAL, AND WAS QUITE WORN. WE WERE CONCERNED THAT WE RECEIVED A PREVIOUSLY OPENED PRODUCT, NO SEAL, WITH ANOTHER PATIENT'S INFORMATION ON THE CARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506065 OSTEOWRAP FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) MBP BACTERIN INTERNATIONAL, INC. B080038-211

    Patients

    Seq Age Sex Outcome Treatment
    1 25550 DA Female