BEUDAMED
    FDA Adverse Event Death Summary report: N

    4.0X14MM BONE SCREW

    MDR report key: 539997 · Received August 18, 2004

    Report

    Report Number
    9617544-2004-00013
    Event Type
    Death
    Date Received
    August 18, 2004
    Date of Event
    May 27, 2003
    Report Date
    July 26, 2004
    Manufacturer
    STRYKER SPINE SA
    Product Code
    KWQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT REPORTEDLY HAD COMPLICATIONS FROM A SURGERY PERFORMED IN 2003. SIX DAYS LATER THE PT WAS DIAGNOSED WITH A PERFORATED ESOPHOGUS ALLEGEDLY DUE TO A DISLODGED SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED TO LEGAL THAT THE PREVIOUSLY REPORTED EVENT (PERFORATED ESOPHAGUS) ALLEGEDLY RESULTED IN PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0X14MM BONE SCREW IMPLANT KWQ STRYKER SPINE SA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death| R