BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE SPINE

    MDR report key: 9215936 · Received October 21, 2019

    Report

    Report Number
    3004499989-2019-00005
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Date of Event
    September 15, 2019
    Report Date
    October 21, 2019
    Manufacturer
    LIFE SPINE, INC.
    Product Code
    MAX
    PMA / PMN Number
    K173182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORRECT SIZED IMPLANT WAS NOT CHOSEN FOR THE SURGERY, THE IMPLANT WORKED AS INTENDED HOWEVER THE WRONG SIZE WAS CHOSEN BY THE SURGEON.

    Description of Event or Problem · 1

    THE IMPLANT WAS PUSHING IT SELF OUT BECAUSE THE SURGEON HAD USED AN IMPLANT THAT WAS TOO SMALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008489 LIFE SPINE PRO LIFT MAX LIFE SPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other