BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASS LP

    MDR report key: 10833210 · Received November 12, 2020

    Report

    Report Number
    1000432246-2020-00008
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    October 13, 2020
    Report Date
    November 12, 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 SPECIFIC RODS IMPLANTED TO THE WRONG PATIENT (MIX-UP). EVEN THOUGH THEY USED THE INCORRECT RODS, THE PATIENT IS FINE AND THE SURGERY WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298970 PASS LP UNID ROD JDN MEDICREA INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention