BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEON3

    MDR report key: 6411319 · Received March 16, 2017

    Report

    Report Number
    9612420-2017-00008
    Event Type
    Injury
    Date Received
    March 16, 2017
    Date of Event
    January 23, 2017
    Report Date
    March 16, 2017
    Manufacturer
    ULRICH GMBH & CO. KG
    Product Code
    NKG
    UDI-DI
    04052536084326
    PMA / PMN Number
    K150650
    Removal / Correction Number
    NA
    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
    192908 NEON3 SCREW, LONGSHAFT, CANNULATED, 4.0MM, LENGTH 32MM NKG ULRICH GMBH & CO. KG CS 3904-40-32 U009004 04052536084326

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention