BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINUTEMAN G3R INTERSPINOUS DEVICE

    MDR report key: 16707249 · Received April 7, 2023

    Report

    Report Number
    MW5116484
    Event Type
    Malfunction
    Date Received
    April 7, 2023
    Date of Event
    April 4, 2023
    Report Date
    April 6, 2023
    Manufacturer
    SPINAL SIMPLICITY, LLC
    Product Code
    PEK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PROVIDER REMOVED IMPLANT AND STATED IT HAD A DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019570 MINUTEMAN G3R INTERSPINOUS DEVICE SPINOUS PROCESS PLATE PEK SPINAL SIMPLICITY, LLC M18491 SIZE 10

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other