BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASS MED

    MDR report key: 7010557 · Received November 8, 2017

    Report

    Report Number
    1000432246-2017-00022
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Date of Event
    October 16, 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 PATIENT WAS INITIALLY OPERATED ON PRIOR TO 2006. THE PATIENT REPORTED THE SCREW BROKE RIGHT AFTER THE FIRST SURGERY. PART OF THE BROKEN IMPLANT WAS RECOVERED DURING THE REVISION SURGERY 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 PATIENT WAS INITIALLY OPERATED ON PRIOR TO 2006. THE PATIENT REPORTED THE SCREW BROKE RIGHT AFTER THE FIRST SURGERY. PART OF THE BROKEN IMPLANT WAS RECOVERED DURING THE REVISION SURGERY ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791676 PASS MED POLYAXIAL CYLINDRICAL PEDICLE SCREW MNI MEDICREA INTERNATIONAL Ø6.0 MM X 46 MM

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R