BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAST QUADRANT RETRACTOR SYSTEM

    MDR report key: 3828056 · Received May 22, 2014

    Report

    Report Number
    1030489-2014-02600
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Report Date
    April 10, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    FSZ
    PMA / PMN Number
    K043602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIGHT SOURCE STARING SMOKING 10 MINUTES INTO A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) CASE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305768 MAST QUADRANT RETRACTOR SYSTEM LIGHT, SURGICAL, CARRIER FSZ MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1