BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASS LP

    MDR report key: 10180087 · Received June 22, 2020

    Report

    Report Number
    1000432246-2020-00003
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Date of Event
    May 27, 2020
    Report Date
    June 22, 2020
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    MNI
    PMA / PMN Number
    K140738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    BOTH BROKEN UNID RODS AND 1 BROKEN MEDICREA SCREW AT L4, IMPLANTED IN (B)(6) 2017. PATIENT DID NOT RECALL A SPECIFIC EVENT BUT STARTED HAVING PAIN AND NOTICED AUDIBLE POPPING. REVISION IS PLANNED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641623 PASS LP UNID ROD MNI MEDICREA INTERNATIONAL B33226012-15 BDE492A4

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention