BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINEWAVE

    MDR report key: 6582083 · Received May 18, 2017

    Report

    Report Number
    6582083
    Event Type
    Malfunction
    Date Received
    May 18, 2017
    Date of Event
    May 2, 2017
    Manufacturer
    SPINEWAVE
    Product Code
    MJO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MOBIC IMPLANT IS STERILE PACKED AS A COMPLETE UNIT. SCRUB TECH ATTACHED UNIT ON AN IMPLANT INSERTER AND HANDED UNIT TO SURGEON. AS THE SURGEON WAS IMPLANTING THE IMPLANT, IT DISASSEMBLED AND HAD TO BE RETRIEVED. SECOND ATTEMPT AT IMPLANTING DEVICE RESULTED IN SAME OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357297 SPINEWAVE MOBIC IMPLANT MJO SPINEWAVE 5252347

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR