BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 1222090 · Received November 5, 2008

    Report

    Report Number
    2520274-2008-00094
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 2008
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWP
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT PROVIDED DURING INITIAL REPORT NOR ON QUESTIONNAIRE RECEIVED FROM THE SURGEON. THE MANUFACTURE SITE AND THE MANUFACTURE DATE CANNOT BE DETERMINED WITHOUT A LOT NUMBER. CANNOT BE DETERMINED WITHOUT A CATALOG NUMBER OR LOT NUMBER. NO INVESTIGATION CAN BE PERFORMED, NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED AND NO CATALOG NUMBER OR LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A PATIENT WITH A 4-LEVEL PLATE, IMPLANTED AT C4-C7 HAD A FOLLOW UP X-RAY TAKEN AND IT WAS NOTED THAT THE SUPERIOR RIGHT SCREW WAS BACKING OUT. PATIENT UNDERWENT REVISION PROCEDURE FOR SCREW REMOVAL AND REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI NONE KWP SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention PLATE| SCREWS