BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UCENTUM

    MDR report key: 5999870 · Received October 5, 2016

    Report

    Report Number
    9612420-2016-00013
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    September 6, 2016
    Report Date
    October 5, 2016
    Manufacturer
    ULRICH GMBH & CO. KG
    Product Code
    NKB
    UDI-DI
    04052536078844
    PMA / PMN Number
    K123717
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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
    652562 UCENTUM SCREW, POLYAXIAL, 6.5MM, LENGTH 50MM NKB ULRICH GMBH & CO. KG CS 3802-065-050 U005518 04052536078844

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention