BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS SPINAL SYSTEM -TRANSLATION SCREW

    MDR report key: 10288690 · Received July 17, 2020

    Report

    Report Number
    10288690
    Event Type
    Malfunction
    Date Received
    July 17, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 15, 2020
    Manufacturer
    BIOMET SPINE LLC
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY TO EXPLANT POLARIS TRANSLATION SYSTEM. THERE IS A QUESTION ABOUT THE COBALT COATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754763 POLARIS SPINAL SYSTEM -TRANSLATION SCREW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB BIOMET SPINE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 26280 DA