BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S4 SET SCREW NEW VERSION

    MDR report key: 858631 · Received May 30, 2007

    Report

    Report Number
    3005673311-2007-00025
    Event Type
    Injury
    Date Received
    May 30, 2007
    Date of Event
    May 23, 2007
    Report Date
    May 30, 2007
    Manufacturer
    AESCULAP IMPLANT SYSTEMS, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES AND ALL AVAILABLE INFORMATION HAVE BEEN FORWARDED TO OUR MANUFACTURER FOR FURTHER ANALYSIS. ADD'L LOT # 51342016.

    Description of Event or Problem · 1

    ORIGINAL SURGERY PERFORMED IN 2007. SPONDYLOLISTHESIS REDUCTION L5-S1 FUSION WITH PROSPACE BONE TLIF. SETSCREW CAME OUT OF TULIP OF SCREW AT L5 RIGHT & LEFT. REOPERATION PERFORMED TWO MONTHS LATER TO RETRIEVE AND REPLACE SETSCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S4 SET SCREW NEW VERSION APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP AESCULAP IMPLANT SYSTEMS, INC. NA 51358626

    Patients

    Seq Age Sex Outcome Treatment
    1 YR