BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 10791354 · Received November 5, 2020

    Report

    Report Number
    3006630150-2020-05358
    Event Type
    Injury
    Date Received
    November 5, 2020
    Date of Event
    October 14, 2020
    Report Date
    December 2, 2020
    Manufacturer
    VERTIFLEX INC.
    Product Code
    NQO
    UDI-DI
    00884662000543
    PMA / PMN Number
    P140004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6 PATIENT CODE 3191: NO CODE AVAILABLE WAS USED BECAUSE THERE IS NOT AN EQUIVALENT FDA CODE FOR SURGICAL INTERVENTION. VISUAL EXAMINATION OF THE RETURNED 101-SERIES 12MM IMPLANT LOT NUMBER 800235 REVEALED THAT THE RIGHT WING OF THE SUPERIOR CAM-LOBE WAS MINUTELY BENT TOWARDS THE MEDIAN LINE. THE IMPLANT FUNCTIONED ACCEPTABLY UPON FUNCTIONAL TESTING AND THE DAMAGE TO IMPLANT INDICATES FAILURE WAS LIKELY DUE TO FORCED DEPLOYMENT AGAINST A RIGID OBSTRUCTION SUCH AS THE SPINOUS PROCESS. THE COMPLAINT OF MALPOSITION OF THE DEVICE WAS CONFIRMED THROUGH DEVICE ANALYSIS. THE PROBABLE CAUSE WAS TRACED TO UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BACK AND LEG PAIN WHEN STANDING. IT WAS ASSESSED THAT THE IMPLANTED SPACER WAS NOT SITTING FLUSH TO THE SPINOLAMINAR JUNCTION. PATIENT THEN UNDERWENT A REVISION PROCEDURE TO REPLACE THE SPACER AND IS DOING WELL POST-OPERATIVELY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BACK AND LEG PAIN WHEN STANDING. IT WAS ASSESS THAT THE IMPLANTED SPACER WAS NOT SITTING FLUSH TO THE SPINOLAMINAR JUNCTION. PATIENT THEN UNDERWENT A REVISION PROCEDURE TO REPLACE THE SPACER AND IS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1259508 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO VERTIFLEX INC. 101-9812 800235 00884662000543

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention