BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RONDO

    MDR report key: 10244410 · Received July 8, 2020

    Report

    Report Number
    3003249380-2020-00002
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 19, 2020
    Report Date
    July 8, 2020
    Manufacturer
    CITIEFFE S.R.L.
    Product Code
    HWC
    UDI-DI
    08032909622429
    PMA / PMN Number
    K113388
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SCREW WAS REMOVED FOR IMPLANT SITE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712605 RONDO TITANIUM CANNULATED SCREW HWC CITIEFFE S.R.L. Screw ø4mm L40mm 0PG072630000 08032909622429

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention