BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARDIS INSERTER

    MDR report key: 1192114 · Received October 7, 2008

    Report

    Report Number
    1649384-2008-00504
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 11, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. EVALUATION IS PENDING.

    Description of Event or Problem · 1

    IN 2008, THE SALES REP REPORTED THAT DURING SURGERY THE SURGEON HAD STARTED TO INSERT THE IMPLANT AND THE IMPLANT TURNED. THE SURGEON ATTEMPTED TO ADJUST THE IMPLANT WITH THE INSERTER WHEN THE TIP BROKE. ADDITIONAL INFO RECEIVED ON 24 SEP 2008 VIA TELEPHONE, THE SALES REP REPORTED THAT DURING SURGERY, THE SURGEON WAS ATTEMPTING TO STRAIGHTEN OUT THE IMPLANT WHEN THE TIP OF THE INSERTER BROKE. THE SURGEON THEN HAD TO RETRIEVE THE BROKEN TIP THAT WAS IN THE WOUND. THERE WAS NO SURGICAL DELAY. THE SURGEON WAS SATISFIED WITH THE PLACEMENT OF THE IMPLANT AND THE SURGEON WAS ABLE TO FINISH THE CASE AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARDIS INSERTER ARDIS LXH ABBOTT SPINE 50CL

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention