BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 4890438 · Received July 6, 2015

    Report

    Report Number
    1030489-2015-01358
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 16, 2015
    Report Date
    June 16, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    MQP
    PMA / PMN Number
    K052261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, INTRA-OP, THE IMPLANT WAS LOADED ON TO THE INSERTER AND PLACED ON THE BORDER OF THE VERTEBRAL BODY. THE SURGEON USED A SMALL MALLET TO GENTLY INTRODUCE THE IMPLANT INTO THE INTERBODY SPACE. AFTER THREE OR FOUR TAPS THE IMPLANT BROKE IN SITU. ANOTHER IMPLANT WAS LOADED AND THE SAME SITUATION OCCURRED. THE IMPLANTS CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434368 N/A SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK USA, INC NA H09J2616

    Patients

    Seq Age Sex Outcome Treatment
    1