BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASS LP

    MDR report key: 10962266 · Received December 7, 2020

    Report

    Report Number
    1000432246-2020-00011
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    September 11, 2020
    Report Date
    December 7, 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

    LEFT ROD IS BROKEN NO DETAILS WERE GIVEN EXCEPT THE PATIENT DID NOT FALL. THE 33MONTHS POSTOP X-RAYS SHOWING THE BREAKAGE. IT LOOKS LIKE THE PLAN WAS NOT RESPECTED IN THE POSTOPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427145 PASS LP UNID ROD JDN MEDICREA INTERNATIONAL B33225512-17 0URHZB1M

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention