BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 10873591 · Received November 20, 2020

    Report

    Report Number
    3006630150-2020-05715
    Event Type
    Injury
    Date Received
    November 20, 2020
    Date of Event
    November 6, 2020
    Report Date
    December 13, 2020
    Manufacturer
    VERTIFLEX INC.
    Product Code
    NQO
    PMA / PMN Number
    P140004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6 PATIENT CODE: 3191: NO CODE AVAILABLE, IS USED AS THERE IS NO ADEQUATE FDA CODE TO DESCRIBE A SURGERY. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SUPERION IMPLANT. UPN: 101-9812. MODEL: 101-9812. SERIAL: NOT APPLICABLE. BATCH: 800253.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO LACK OF EFFECTIVE THERAPY. THE PATIENT IS DOING WELL POST OPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE TWO EXPLANTED DEVICES WERE DISCARDED BY THE FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SUPERION IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY FROM THE IMPLANTED DEVICES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE IN WHICH THE TWO DEVICES WERE EXPLANTED. THE CURRENT LOCATION OF THE DEVICES IS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341367 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO VERTIFLEX INC. 101-9812 700065

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention