BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UCENTUM

    MDR report key: 5142094 · Received October 9, 2015

    Report

    Report Number
    9612420-2015-00010
    Event Type
    Malfunction
    Date Received
    October 9, 2015
    Date of Event
    September 14, 2015
    Report Date
    October 9, 2015
    Manufacturer
    ULRICH GMBH & CO. KG
    Product Code
    NKB
    PMA / PMN Number
    K123717
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ULRICH MEDICAL GMBH (MANUFACTURER) IS SUBMITTING THIS REPORT FOR BOTH ULRICH MEDICAL GMBH AND ULRICH MEDICAL USA (IMPORTER) EXEMPTION (B)(4)

    Description of Event or Problem · 1

    SCREW BREAKAGE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671947 UCENTUM SCREW POLYAXIAL 07, 5MM, LENGTH 55MM NKB ULRICH GMBH & CO. KG CS 3802-075-055 U003861

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention