BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASS LP

    MDR report key: 7010552 · Received November 8, 2017

    Report

    Report Number
    1000432246-2017-00021
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Date of Event
    June 15, 2017
    Report Date
    October 30, 2017
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    MNI
    PMA / PMN Number
    K080099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RODS WERE IMPLANTED ON (B)(6) 2016. IN (B)(6) 2017, THEY BROKE DUE TO A NONUNION THERE WAS NOT ENOUGH ANTERIOR STRUCTURAL SUPPORT AFTER THE TUMOR RESECTION AND KYPHOSIS CORRECTION. HE WAS REVISED ON (B)(6) 2017. MEDICREA INTERNATIONAL IS SUBMITTING THIS REPORT ON BEHALF OF IMPORTER: (B)(4). EXEMPTION E2017030.

    Description of Event or Problem · 0

    THE RODS WERE IMPLANTED ON (B)(6) 2016. IN (B)(6) 2017, THEY BROKE DUE TO A NONUNION. THERE WAS NOT ENOUGH ANTERIOR STRUCTURAL SUPPORT AFTER THE TUMOR RESECTION AND KYPHOSIS CORRECTION. HE WAS REVISED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791683 PASS LP UNID TI DUAL DIAMETER ROD Ø3.5/Ø5.5 MM MNI MEDICREA INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R