BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTURA IMPLANTS

    MDR report key: 12091976 · Received June 30, 2021

    Report

    Report Number
    12091976
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    July 6, 2020
    Report Date
    June 18, 2021
    Manufacturer
    ASTURA MEDICAL
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT BROUGHT BACK TO SURGERY FROM PREVIOUS ADMISSION DUE TO LOCKING CAPS ON THE CONSTRUCTION BECOMING LOOSE. TYPE OF SURGERY: SPINAL FUSION. TYPE OF EQUIPMENT: IMPLANTS. ELDERLY MALE HAD ELECTIVE T6-L2 INSTRUMENTATION REVISION AND EXPLORATION OF FUSION. IT WAS FOUND IN SURGERY THAT SPINE CAPS L1/L2 BILATERALLY AND T10 ON LEFT WERE DISCONNECTED. PATIENT HAS STAGE IV METASTATIC MELANOMA WITH METASTASIS TO THE SPINE AND IS S/P (STATUS POST) RADIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992943 ASTURA IMPLANTS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB ASTURA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 23725 DA