BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASS LP

    MDR report key: 10842918 · Received November 16, 2020

    Report

    Report Number
    1000432246-2020-00009
    Event Type
    Malfunction
    Date Received
    November 16, 2020
    Date of Event
    October 19, 2020
    Report Date
    November 16, 2020
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    JDN
    PMA / PMN Number
    K140738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS GETTING SOMETHING OUT OF A CABINET AND STARTED TO FEEL PAIN. BOTH RODS ARE BROKEN AROUND L4-L5. THERE WILL BE A REVISION SURGERY ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312811 PASS LP UNID COCR 5.5MM AND 6.0 MM JDN MEDICREA INTERNATIONAL B33225512-08, B33226012-08 0W1X4Q9J

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention