BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBELISC LE

    MDR report key: 8456488 · Received March 27, 2019

    Report

    Report Number
    9612420-2019-00007
    Event Type
    Injury
    Date Received
    March 27, 2019
    Date of Event
    February 14, 2019
    Report Date
    March 27, 2019
    Manufacturer
    ULRICH GMBH & CO. KG
    Product Code
    MQP
    UDI-DI
    04052563113804
    PMA / PMN Number
    K060416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    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

    ENDPLATE DETACHED DURING POST FIXATION FINAL TIGHTENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249996 OBELISC LE LATERAL END PLATE MQP ULRICH GMBH & CO. KG CS 2916-10 NI 04052563113804

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization