BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UCENTUM

    MDR report key: 4742349 · Received April 29, 2015

    Report

    Report Number
    9612420-2015-00001
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    February 19, 2015
    Report Date
    March 10, 2015
    Manufacturer
    ULRICH GMBH & CO. KG
    Product Code
    NKB
    PMA / PMN Number
    K123717
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SCREW BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282599 UCENTUM SCREW - REST UNK NKB ULRICH GMBH & CO. KG UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK