BEUDAMED
    FDA Adverse Event Other Summary report: N

    GRAFT FIRST

    MDR report key: 6166301 · Received December 7, 2016

    Report

    Report Number
    MW5066631
    Event Type
    Other
    Date Received
    December 7, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 7, 2016
    Manufacturer
    SPINAL SURGICAL STRATEGIES
    Product Code
    FMF
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON PLACING PRESSURE ON THE DEVICE TO PLACE BONE GRAFT BETWEEN THE DISC SPACE, THE PRODUCT OPENED AT THE TIP AND THE MARKING BEAD MIXED WITH THE GRAFT. IT WAS DEEMED SAFER TO LEAVE THE MARKER THAN TO RETRIEVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804610 GRAFT FIRST GRAFT FIRST FMF SPINAL SURGICAL STRATEGIES 9434885

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other