BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHROS MIS

    MDR report key: 16582564 · Received March 21, 2023

    Report

    Report Number
    3010197239-2022-00001
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    November 30, 2022
    Report Date
    March 3, 2023
    Manufacturer
    CAMBER SPINE TECHNOLOGIES
    Product Code
    NKB
    PMA / PMN Number
    K180980
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INTITIAL SURGERY WAS PERFORMED IN PATIENT ON (B)(6) 2022. POST-OP X-RAY INDICATED THE SURGERY WENT WELL WITH NO ANOMOLIES. LATER DURING A ROUTINE X-RAY SCAN DONE ON (B)(6)2022 IT WAS FOUND OUT THAT AN ORTHROS MIS SET SCREW WAS FREELY FLOATING INSIDE THE PATIENT. THE POSTERIOR CONSTRUCT IMPLANTED ON THAT DAY WAS BILATERAL FROM L4-S1. A REVISION SURGERY WAS DONE ON (B)(6) 2022. THE PATIENT WAS OBSESE AND HAD A SCLEROTIC BONE WHICH MADE THE SURGERY LITTLE BIT CHALLENGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24918 ORTHROS MIS ORTHROS MIS SET SCREW NKB CAMBER SPINE TECHNOLOGIES CM-002-10 BG16021C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention