BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 10795963 · Received November 5, 2020

    Report

    Report Number
    3006630150-2020-05392
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 27, 2020
    Report Date
    November 5, 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 · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SUPERION IMPLANT: UPN: (B)(4), MODEL: 101-9810, SERIAL: NA, BATCH: 800306.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE DEVICE WAS NOT ABLE TO DEPLOY. AN ATTEMPT WAS MADE TO DEPLOY AT DIFFERENT DEPTHS, REPOSITION THE CANNULA AND REAMER; HOWEVER, NOTHING RESOLVED THE ISSUE. IT WAS CONFIRMED THAT THE IMPLANT WAS PROPERLY CONNECTED TO THE INSERTER, BUT ASSESSED THAT THERE WAS POSSIBLY THICK BONE, OSTEOPHYTES, OR OTHER SOFT TISSUE OR BONE THAT COULD HAVE CAUSED RESISTANCE. THE PROCEDURE WAS ABORTED AND IMPLANT WAS NOT PLACED. PATIENT RECOVERY WAS ROUTINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255624 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO VERTIFLEX INC. 101-9812 700082 00884662000543

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention