BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S4 POLYAXIAL SCREW 6.0X35MM

    MDR report key: 859574 · Received June 1, 2007

    Report

    Report Number
    3005673311-2007-00027
    Event Type
    Injury
    Date Received
    June 1, 2007
    Report Date
    May 30, 2007
    Manufacturer
    AESCULAP IMPLANT SYSTEMS, INC.
    Product Code
    KWQ
    Report Source
    Manufacturer report
    Reporter Location
    VA, US

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION HAVE BEEN FORWARDED TO OUR MANUFACTURER IN ANOTHER COUNTRY, FOR FURTHER ANALYSIS.

    Description of Event or Problem · 1

    THE INITIAL SURGERY WAS A LUMBAR FUSION L5-S1. TWO SCREWS BROKE AT S1, APPROXIMATELY FOUR MONTHS AFTER SURGERY. REVISION PERFORMED ON L5-S1 IN 2007. IMPLANTS GIVEN TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S4 POLYAXIAL SCREW 6.0X35MM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWQ AESCULAP IMPLANT SYSTEMS, INC. NA 51270987

    Patients

    Seq Age Sex Outcome Treatment
    1 YR