BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 1915281 · Received November 17, 2010

    Report

    Report Number
    2520274-2010-00211
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Report Date
    October 26, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. SUBJECT DEVICE HAS NOT BEEN EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO PART/LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    PT STATUS POST IMPLANTATION WITH THREE PLATES AND SCREWS HAS AN UNSTABLE CHEST. SURGEON NOTED STERNUM IS NOT STABLE AT INFERIOR PART OF STERN TOWARD THE XIPHOID, THE BOTTOM PLATE CAME LOOSE AND DEHISCENCE OCCURRED. SURGEON IS NOT REMOVING THE HARDWARE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI