BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHROS MIS

    MDR report key: 20224647 · Received September 16, 2024

    Report

    Report Number
    3010197239-2024-00001
    Event Type
    Injury
    Date Received
    September 16, 2024
    Date of Event
    August 22, 2024
    Report Date
    August 27, 2024
    Manufacturer
    CAMBER SPINE TECHNOLOGIES
    Product Code
    NKB
    UDI-DI
    B030ORM35C0
    PMA / PMN Number
    K133366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2024 A 62 YEAR OLD MALE PATIENT HAD GONE THROUGH SURGERY DURING WHICH TWO ORTHORS MIS RODS (ORM-35C) WERE IMPLANTED. AS PER PATIENT DESCRIPTION WHEN HE WAS DOING DISHES WHILE LOADING/UNLOADING DISHWASHER, HE HEARD A LOUD POP IN HIS BACK. THE PATIENT FELT SOME PAIN AND KNEW SOMETHING WAS WRONG. PATIENT MADE A FOLLOW UP APPOINTMENT AND WAS SEEN IN OFFICE ON (B)(6) 2024 IN THE MORNING. UPON X-RAYING PATIENT IT WAS DISCOVERED THAT BOTH 35MM RODS WERE BROKEN. A REVISION SURGERY WAS SCHEDULED ON (B)(6) 2024. DURING THE REVISION SURGERY THE ORTHROS MIS RODS WERE EXPLANTED ALONG WITH THE PEDICLE SCREW AND ITS RESPECTIVE SET SCREWS. NEW ORTHROS MIS RODS ALONG WITH NEW PEDICLE SCREWS AND SET SCREWS WERE IMPLANTED. THE PATIENT IS NO LONGER FEELING PAIN POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386245 ORTHROS MIS Thoracolumbosacral pedicle screw system NKB CAMBER SPINE TECHNOLOGIES ORM-35C BG06222B B030ORM35C0

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention