BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBO

    MDR report key: 1000541 · Received February 15, 2008

    Report

    Report Number
    9617544-2008-00015
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    April 9, 2007
    Report Date
    January 27, 2008
    Manufacturer
    STRYKER SPINE BRDEAUX
    Product Code
    KWQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    DURING SURGERY, THE TIP OF THE SCREWDRIVER BROKE. A PIECE OF THE BROKEN PART FELL INTO THE PTS BODY AND THE SURGEON REMOVED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBO IMPLANT KWQ STRYKER SPINE BRDEAUX NA 34814

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other