BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNID ROD COCR Ø5.5 MM

    MDR report key: 7126032 · Received December 18, 2017

    Report

    Report Number
    1000432246-2017-00023
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    November 22, 2017
    Report Date
    December 7, 2017
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    MNI
    PMA / PMN Number
    K141398
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SPINAL ROD WAS IMPLANTED ON (B)(6) 2015. ON (B)(6) 2017 THE FRACTURE WAS DETECTED ON X-RAY. (B)(4). EXEMPTION E2017030.

    Description of Event or Problem · 0

    SPINAL ROD WAS IMPLANTED ON (B)(6) 2015. ON (B)(6) 2017 THE FRACTURE WAS DETECTED ON X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905930 UNID ROD COCR Ø5.5 MM SPINAL ROD MNI MEDICREA INTERNATIONAL COCR Ø5.5 MM

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention