BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 10145247 · Received June 11, 2020

    Report

    Report Number
    3006630150-2020-02440
    Event Type
    Injury
    Date Received
    June 11, 2020
    Date of Event
    May 13, 2020
    Report Date
    July 23, 2020
    Manufacturer
    VERTIFLEX INC.
    Product Code
    NQO
    PMA / PMN Number
    P140004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. ADDITIONALLY, MIGRATION OR DISLODGEMENT OF IMPLANT FROM THE ORIGINAL POSITION IS NOTED WITHIN THE DFU AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE DISCARDED BY THE MEDICAL FACILITY. ADDITIONAL SUSPECT MEDICAL DEVICES INVOLVED: MODEL #:101-9812. LOT #: 800330. DESCRIPTION: SUPERION IDS 12MM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN IMPLANT PROCEDURE WAS ABORTED DUE TO AN UNKNOWN REASON. ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE IMPLANT PROCEDURE, AFTER THE FIRST DEVICE WAS BEING IMPLANT, THE SECOND DEVICE WAS BEING DEPLOYED AND CAME INTO CONTACT WITH THE FIRST DEVICE WHICH CAUSED IT TO TURN AND FALL OUT OF POSITION. IT WAS UNCLEAR IF THAT SPINOUS PROCESS WAS FRACTURED. THE FIRST DEVICE TURNED IN SUCH A MANNER THAT IT HAD TO BE REMOVED. THE PHYSICIAN ASSESSED A POSSIBLE SPINOUS PROCESS FRACTURE AT L4. THE DECISION WAS MADE THAT BOTH DEVICES HAD TO BE REMOVED AND THE PATIENT BE OBSERVED. THE PATIENT IS NOT IN PAIN FROM THE PROCEDURE BUT STILL HAS HIS ORIGINAL SYMPTOMS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN IMPLANT PROCEDURE WAS ABORTED DUE TO AN UNKNOWN REASON. ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE IMPLANT PROCEDURE, AFTER THE FIRST DEVICE WAS BEING IMPLANT, THE SECOND DEVICE WAS BEING DEPLOYED AND CAME INTO CONTACT WITH THE FIRST DEVICE WHICH CAUSED IT TO TURN AND FALL OUT OF POSITION. IT WAS UNCLEAR IF THAT SPINOUS PROCESS WAS FRACTURED. THE FIRST DEVICE TURNED IN SUCH A MANNER THAT IT HAD TO BE REMOVED. THE PHYSICIAN ASSESSED A POSSIBLE SPINOUS PROCESS FRACTURE AT L4. THE DECISION WAS MADE THAT BOTH DEVICES HAD TO BE REMOVED AND THE PATIENT BE OBSERVED. THE PATIENT IS NOT IN PAIN FROM THE PROCEDURE BUT STILL HAS HIS ORIGINAL SYMPTOMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANT PROCEDURE WAS ABORTED DUE TO AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606951 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO VERTIFLEX INC. 101-9810 700055

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R