BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULATED POLY SCREWDRIVER II-MOD

    MDR report key: 1062898 · Received June 19, 2008

    Report

    Report Number
    1649384-2008-00317
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 19, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    HXX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    IN 2008, THE PT UNDERWENT SURGERY. THE SURGEON WAS IMPLANTING THE SCREWS WHEN THE SCREWDRIVER SPLINTERED. THE SURGEON ATTEMPTED TO RETRIEVE ALL THE FRAGMENTS. THE X-RAY SHOWED NO FRAGMENTS IN THE PT. THE SURGEON ASSUMES THE FRAGMENTS WERE PICKED UP WITH THE SUCTION. THERE WAS A SURGICAL DELAY OF TWO HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED POLY SCREWDRIVER II-MOD PATHFINDER HXX ABBOTT SPINE 29CQ

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention