BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBX

    MDR report key: 9665340 · Received February 4, 2020

    Report

    Report Number
    9665340
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Date of Event
    November 25, 2019
    Report Date
    December 2, 2019
    Manufacturer
    MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC.
    Product Code
    MQV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TOTAL HIP ARTHROPLASTY: SURGEON REQUESTED 4 OF MFT BIOLOGICS AFT STRAIGHT TUBE (REF: (B)(4)) BE OPENED TO THE FIELD. WITH TWO OF THEM, THE SURGEON COULD NOT GET THE PRODUCT OUT OF THE TUBE. HE ASKED FOR MORE AND WE HAD NO MORE OF THE STRAIGHT TUBES AND HAD TO OPEN A DIVERTED TUBE (REF: (B)(4)). THE DIVERTED ONE DID NOT WORK EITHER. I TOOK THE DIVERTED TUBE AND TWO STRAIGHT TUBES OFF THE FIELD AND MADE SURE THEY WERE WASTED IN THE PATIENT CHART. I PUT THE DIVERTED TUBE BACK IN ITS PACKAGE BUT WAS NOT ABLE TO KNOW WHAT PACKAGES CORRELATED WITH THE TWO FAULTY STRAIGHT TUBES. THIS REPORT INCLUDES 1 AFT DIVERTED TUBE (3/4 FILLED) AND ITS DETAILS AND 2 AFT STRAIGHT TUBE (1/2 FILLED) WITH ONLY LIMITED DETAILS ON 2ND PACKAGE (TUBE WAS SAVED BUT BOX NOT SAVED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126616 DBX FILLER, BONE VOID, CALCIUM COMPOUND MQV MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 32485 DA