BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASS LP

    MDR report key: 10277810 · Received July 15, 2020

    Report

    Report Number
    1000432246-2020-00005
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    June 18, 2020
    Report Date
    July 15, 2020
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    JDN
    PMA / PMN Number
    K140738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    RIGHT UNID ROD IS BROKEN (IMPLANTED IN (B)(6) 2016). PATIENT REPORTED THE BREAK SOUNDED LIKE A GUNSHOT AND HER BACK BEGAN TO HURT. NO OTHER INFORMATION ON HOW IT HAPPENED. SHE IS OTHERWISE NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744777 PASS LP UNID ROD JDN MEDICREA INTERNATIONAL B33226012 885CE220

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention