BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAGODA

    MDR report key: 10563795 · Received September 21, 2020

    Report

    Report Number
    1722511-2020-00024
    Event Type
    Injury
    Date Received
    September 21, 2020
    Date of Event
    September 13, 2019
    Report Date
    September 10, 2020
    Manufacturer
    ORTHO DEVELOPMENT
    Product Code
    NKB
    PMA / PMN Number
    K142146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT REPRESENTS THE 3RD OF 3 REPORTS SUBMITTED FOR THE 3 SCREWS INVOLVED IN THE EVENT. THE 3 SCREWS WERE FROM 2 LOT NUMBERS: A151506 AND A149024. FOR THIS, THE 3RD SCREW, IT IS UNKNOWN WHICH LOT NUMBER IT CAME FROM SO THE INFORMATION IS REPORTED HERE AS FOLLOWS: LOT NUMBER - A151506 OR A149024. EXPIRATION DATE - 30-JUN-2020 (A151506) OR 30-APR-2020 (A149024). DATE OF MANUFACTURE - 13-JUL-2015 (A151506) OR 12-MAY-2015 (A149024)

    Description of Event or Problem · 1

    THIS REPORT REPRESENTS THE 3RD OF 3 REPORTS SUBMITTED FOR EACH OF THE 3 SCREWS INVOLVED IN THE FOLLOWING EVENT: ON (B)(6) 2016, SURGERY WAS PERFORMED ON A CANCER PATIENT WHO HAD A NEOPLASTIC VERTEBRAL BODY FRACTURE AT L1. AT SOME POINT AFTER THE OPERATION, IT WAS DISCOVERED THAT 3 SCREWS HAD BROKEN (THE LEFT SCREW AT L2 AND BOTH THE LEFT AND RIGHT SCREWS AT L3). OVER TIME, KYPHOSIS INCREASED AND THE END OF THE ROD WAS PUSHED UP TO THE EXTENT THAT THE SKIN WAS RAISED, CAUSING PAIN. ON (B)(6) 2019, THE ALL THE HARDWARE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025492 PAGODA PEDICLE SCREW NKB ORTHO DEVELOPMENT 752-6550-26A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR