BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDFUSE

    MDR report key: 8629880 · Received May 21, 2019

    Report

    Report Number
    3005977257-2019-00010
    Event Type
    Malfunction
    Date Received
    May 21, 2019
    Date of Event
    December 27, 2018
    Report Date
    May 21, 2019
    Manufacturer
    SPINEFRONTIER INC.
    Product Code
    MNI
    PMA / PMN Number
    K092420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    SPINEFRONTIER INVESTIGATION INTO THIS MATTER INCLUDED; A REVIEW OF THE DEVICE HISTORY RECORD, WHICH REVEALED THAT THIS LOT PASSED ALL INCOMING INSPECTION AND WAS RELEASED TO DISTRIBUTION WITHOUT ANY CONCESSIONS. COMPLAINT TRENDING DETERMINE THIS SYSTEM WAS RELEASED IN 2009, THIS WAS THE FIRST DOCUMENTED OCCURRENCE OF THIS NATURE THEREFORE THE RISK CLASSIFICATION. REMAINS ACCEPTABLE FOLLOWING A REVIEW OF ALL RISK DOCUMENTATION . A TOLERANCE ANALYSIS REVIEW ESTABLISHES THAT IN WORST CASES THERE COULD BE A FIT ISSUE, THIS PROMPTED A DRAWING UPDATE TO ENSURE THAT THE DEVICE HAS ENOUGH CLEARANCE WITH THE IMPLANT AND THE DRIVERS AND WAS SUBSEQUENTLY REWORKED TO THE NEW DRAWING SPECIFICATIONS. SPINEFRONTIER IS CONSIDERING IT'S INVESTIGATION INTO THIS MATTER CLOSED, NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423728 PEDFUSE PEDFUSE MNI SPINEFRONTIER INC. SI80074 CT12E038

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention