BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEON3

    MDR report key: 5996463 · Received October 4, 2016

    Report

    Report Number
    9612420-2016-00010
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    September 5, 2016
    Report Date
    September 29, 2016
    Manufacturer
    ULRICH GMBH & CO. KG
    Product Code
    NKG
    UDI-DI
    04052536084210
    PMA / PMN Number
    K150650
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ULRICH MEDICAL GMBH (MANUFACTURER) IS SUBMITTING THIS REPORT FOR BOTH ULRICH MEDICAL GMBH AND ULRICH MEDICAL USA (IMPORTER) EXEMPTION # E2014011

    Description of Event or Problem · 0

    SCREW BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649820 NEON3 SCREW, 3.5MM, LENGTH 18MM NKG ULRICH GMBH & CO. KG CS 3902-35-18 U007382 04052536084210

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention