BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 891841 · Received October 22, 2004

    Report

    Report Number
    2916714-2004-00041
    Event Type
    Malfunction
    Date Received
    October 22, 2004
    Report Date
    October 20, 2004
    Manufacturer
    AESCULAP AG & CO KG
    Product Code
    KWQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT FELT A LITTLE MORE PAIN RECENTLY, BUT APART FROM THAT DOING OK. X-RAYS WERE TAKEN IN 2004 (APPROX 4 MOS POST OP) AND IT WAS NOTED THAT ONE OF THE SCREWS HAD BROKEN. THE SURGEON FEELS THAT THE PT MAY STILL FUSE. NO RE-OPERATION HAS BEEN SCHEDULED. A DETERMINATION WILL BE MADE IN A FEW MOS. SCREW ITEM # WAS NOT PROVIDED. IT WAS REPORTED THAT THE SCREW WAS 6MM WIDE AND EITHER A 35MM (AESCULAP PART# SW773T) OR 40MM (ASECULAP PART# SW774T) IN LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK S4 POLYAXIAL SCREW KWQ AESCULAP AG & CO KG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR