BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORIAL STEM INSERTER

    MDR report key: 3905568 · Received June 25, 2014

    Report

    Report Number
    MW5036893
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 5, 2014
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NIPPLE TIP OF A CORIAL STEM INSERTER BROKE OFF, PRESUMABLE DURING INSERTION IN A PT. WHEN STAFF WERE GATHERING SUPPLIES FOLLOWING THE SURGERY, IT WAS NOTED THAT THE TIP WAS MISSING AND PRESUMABLY BROKE OFF. UNABLE TO LOCATE THE TIP, XRAYS COMPLETED WITH NO VISUALIZATION OF THE INSTRUMENT TIP. ESTIMATION WITH COMPARISON TO ANOTHER INSERTER IS THAT THE TIP WAS APPROX 5MM. THERE IS NO KNOWN ADVERSE EFFECTS TO THE PT RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370799 CORIAL STEM INSERTER CORIAL STEM INSERTER LXH PG219098

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR