BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DBX PUTTY, 5CC

    MDR report key: 4162877 · Received October 8, 2014

    Report

    Report Number
    2249062-2014-00003
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MUSCULOSKELETAL TRANSPLANT FOUNDATION
    Product Code
    MQV
    PMA / PMN Number
    K040262
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY REVIEW: THE DONOR WAS APPROPRIATELY SCREENED AND TESTED IN ACCORDANCE WITH MTF'S DONOR RELEASE CRITERIA AND THE TISSUE WAS DEEMED SUITABLE FOR PROCESSING. THE DONOR TISSUE WAS ASEPTICALLY PROCESSED. FINAL PRODUCT STERILITY RESULTS WERE DOCUMENTED AS NEGATIVE. (B)(4). TO DATE, THERE HAVE BEEN NO OTHER ADVERSE EVENTS REPORTED IN ANY OTHER RECIPIENT'S OF THE DONOR TISSUE. NOTE: THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT IS CURRENTLY CONDUCTING AN INVESTIGATION AND HAVE REPORTED THAT, THUS FAR, THEY HAVE FOUND NO EVIDENCE THAT ORGANISM ASSOCIATED WITH THE PATIENT'S INFECTION IS RELATED TO THE HOSPITAL'S ENVIRONMENT OR THE TRANSPLANTED TISSUES OR MEDICAL DEVICES.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A PATIENT UNDERWENT A SPINE PROCEDURE AND WAS IMPLANTED WITH UNIT OF MTF DBX PUTTY, AN MTF T-PLIF SPACER, LIFENET CANCELLOUS CHIPS, AND SYNTHES DEPUY METAL HARDWARE. IT WAS REPORTED THAT THE PATIENT DEVELOPED (DATE UNK) A POST-OPERATIVE WOUND INFECTION RELATED TO A(B)(6) 2014); RESPONSE NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631377 DBX PUTTY, 5CC BONE VOID FILLER MQV MUSCULOSKELETAL TRANSPLANT FOUNDATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MTF T-PLIF SPACER, (S/N (B)(4)) - MEDWATCH| LIFENET CANCELLOUS CHIPS, (SERIAL/LOT NUMBER UNK)| # 3001236616-2014-0036 FILED WITH FDA/CBER.| EXPEDIUM LOCKING CAPS, (PART # 179702000)