BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASS LP

    MDR report key: 10610401 · Received September 30, 2020

    Report

    Report Number
    1000432246-2020-00006
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    August 28, 2020
    Report Date
    September 30, 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

    BOTH UNID RODS IMPLANTED IN (B)(6) 2017 ARE BROKEN IN LOWER LUMBAR REGION. NO DETAILS WERE GIVEN OF HOW THE RODS BROKE, PATIENT DOES NOT HAVE AN INJURY, IS ASYMPTOMATIC, AND DOES NOT REQUIRE A SURGERY AS OF NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071426 PASS LP UNID COCR ROD Ø5.5MM JDN MEDICREA INTERNATIONAL B33225512-17 5437DCB0

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention