BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASS LP

    MDR report key: 7891736 · Received September 19, 2018

    Report

    Report Number
    1000432246-2018-00013
    Event Type
    Malfunction
    Date Received
    September 19, 2018
    Date of Event
    August 15, 2018
    Report Date
    September 21, 2018
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    MNI
    PMA / PMN Number
    K100297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT BENT FORWARD AND HEARD A POP IN HER BACK AND HAD PAIN IN THAT AREA. IT WAS FOUND THAT THERE WERE TWO FRACTURED RODS. MEDICREA INTERNATIONAL IS SUBMITTING THIS REPORT ON BEHALF OF IMPORTER: (B)(4). EXEMPTION E2017030.

    Description of Event or Problem · 0

    THE PATIENT BENT FORWARD AND HEARD A POP IN HER BACK AND HAD PAIN IN THAT AREA. IT WAS FOUND THAT THERE WERE TWO FRACTURED RODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731906 PASS LP UNID ROD MNI MEDICREA INTERNATIONAL CFA97875

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention