BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS(TM) 5.5 SPINAL SYSTEM

    MDR report key: 8435571 · Received March 20, 2019

    Report

    Report Number
    8435571
    Event Type
    Injury
    Date Received
    March 20, 2019
    Date of Event
    March 4, 2019
    Report Date
    March 18, 2019
    Manufacturer
    BIOMET SPINE LLC
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT BENT OVER AND FELT A "POP." SPINAL ROD NOTED TO BE BROKEN ON X-RAY. DEVICE HAD BEEN IN PLACE FOR APPROX. 3 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231236 POLARIS(TM) 5.5 SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP BIOMET SPINE LLC 14-500585

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R