BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASS LP

    MDR report key: 11611368 · Received April 2, 2021

    Report

    Report Number
    1000432246-2021-00001
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    February 24, 2021
    Report Date
    April 2, 2021
    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 ARE BROKEN IN LOWER LUMBAR REGION FOR THIS PATIENT. PATIENT DOES NOT RECALL ANY SPECIFIC INCIDENT OF HOW THE RODS BROKE. THE PATIENT HAS PAIN IN HER LOWER BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507215 PASS LP UNID ROD JDN MEDICREA INTERNATIONAL B33226012-09 0V79NPC1

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention