BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASS LP

    MDR report key: 7922598 · Received October 1, 2018

    Report

    Report Number
    1000432246-2018-00014
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Date of Event
    July 15, 2018
    Report Date
    October 2, 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

    ROD BREAKAGE ABOUT 12 MONTHS AFTER IMPLANTATION. NO ADDITIONAL SURGICAL INTERVENTION AT THIS TIME BECAUSE PATIENT IS ASYMPTOMATIC. (B)(4). EXEMPTION E201703.

    Description of Event or Problem · 0

    ROD BREAKAGE ABOUT 12 MONTHS AFTER IMPLANTATION. NO ADDITIONAL SURGICAL INTERVENTION AT THIS TIME BECAUSE PATIENT IS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765639 PASS LP UNID ROD MNI MEDICREA INTERNATIONAL 0DBED944

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR