BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 10145825 · Received June 11, 2020

    Report

    Report Number
    3006630150-2020-02445
    Event Type
    Injury
    Date Received
    June 11, 2020
    Date of Event
    May 22, 2020
    Report Date
    July 6, 2020
    Manufacturer
    VERTIFLEX INC.
    Product Code
    NQO
    PMA / PMN Number
    P140004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. ADDITIONAL SUSPECT MEDICAL DEVICES INVOLVED: MODEL: 101-9812; LOT#: 800095; DESCRIPTION: SUPERION IDS 12MM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DID NOT RECEIVE THE EXPECTED RELIEF FROM THE IMPLANTS AND WANTED THEM REMOVED. THE DEVICES WERE EXPLANTED WITHOUT ANY COMPLICATIONS.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. ADDITIONAL SUSPECT MEDICAL DEVICES INVOLVED: MODEL: NO INFORMATION, LOT #: NO INFORMATION, DESCRIPTION: NO INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DID NOT RECEIVE THE EXPECTED RELIEF FROM THE IMPLANTS AND WANTED THEM REMOVED. THE DEVICES WERE EXPLANTED WITHOUT ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605788 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO VERTIFLEX INC. 101-9812 800087

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention