BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEON3

    MDR report key: 5985009 · Received September 28, 2016

    Report

    Report Number
    9612420-2016-00011
    Event Type
    Malfunction
    Date Received
    September 28, 2016
    Date of Event
    September 5, 2016
    Report Date
    October 4, 2016
    Manufacturer
    ULRICH GMBH & CO. KG
    Product Code
    NKG
    UDI-DI
    04052536084388
    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
    637214 NEON3 SCREW, 4.0MM, LENGTH 26MM NKG ULRICH GMBH & CO. KG CS 3905-40-26 U007623 04052536084388

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention