BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RONDO'

    MDR report key: 9817107 · Received March 11, 2020

    Report

    Report Number
    3003249380-2020-00001
    Event Type
    Malfunction
    Date Received
    March 11, 2020
    Date of Event
    February 8, 2020
    Report Date
    March 11, 2020
    Manufacturer
    CITIEFFE S.R.L.
    Product Code
    HWC
    UDI-DI
    08032909622436
    PMA / PMN Number
    K113388
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    THE SCREW BROKE DURING THE SURGERY, IN PARTICULAR DURING THE SCREWING INTO THE PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285230 RONDO' TITANIUM CANNULATED SCREW HWC CITIEFFE S.R.L. Screw ø4mm L45mm 0PI154350000 08032909622436

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR