BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED POLY SCREWDRIVER II-MOD

    MDR report key: 1062303 · Received June 18, 2008

    Report

    Report Number
    1649384-2008-00322
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 18, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. EVAL IS PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    IN 2008, THE SALES REP REPORTED THAT ON AN UNK DATE, THE SURGEON WAS LOADING THE SCREWS AND THE DRIVER WOULD NOT ATTACH TO THE DRIVER. THE SURGEON USED ANOTHER INSTRUMENT IN THE KIT TO FINISH THE CASE AS INTENDED. THE MALFUNCTION HAS RESULTED IN AN ADVERSE EVENT IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED POLY SCREWDRIVER II-MOD INCOMPASS HXX ABBOTT SPINE 43MN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK