BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 1883387 · Received October 21, 2010

    Report

    Report Number
    2520274-2010-00186
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Report Date
    September 28, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. SUBJECT DEVICE WAS NO EXPLANTED. SYNTHES IS UNABLE TO PROVIDE THE MANUFACTURER, PMA/510K NUMBER AND/OR THE DATE OF MANUFACTURE 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 LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    PATIENT STATUS POST TWO LEVEL, L3, L5 SYNFIX IMPLANTATION RETURNED TO SURGEON'S OFFICE. AN X-RAY SHOWED ONE SCREW WAS BROKEN IN EACH LEVEL AT THE INTERFACE OF THE IMPLANT. SURGEON NOTED PATIENT WAS HEALED AND NO FURTHER SURGERY WAS REQUIRED. THS IS ONE OF TWO REPORTS FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 SYNFIX IMPLANT