BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2120302 · Received June 2, 2011

    Report

    Report Number
    2520274-2011-00179
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. UNABLE TO PROVIDE THE MANUFACTURER, PMA/510K NUMBER AND/OR THE MANUFACTURE DATE AS NO PRODUCT WAS RETURNED AND NO PART/LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO PART/LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    PATIENT STATUS POST CLICK-X CONSTRUCT IMPLANTATION LEVEL L5-S1 RETURNED TO SURGEON. PATIENT COMPLAINED SHE COULD FEEL THE HARDWARE. AN X-RAY SHOWED PATIENT DEVELOPED ADJACENT LEVEL DISEASE AND SURGEON NOTED THE CONSTRUCT WAS HEALED AND FUSED; HARDWARE WAS REMOVED, 4 SCREWS 4 CAPS AND 2 RODS. SURGEON NOTED THE CONSTRUCT WAS INTACT AND FUNCTIONED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI CONSTRUCT HRS SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention SCREW CAP ROD