BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 10408544 · Received August 14, 2020

    Report

    Report Number
    3006630150-2020-03428
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    July 20, 2020
    Report Date
    September 1, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE TECHNICAL ANALYSIS: VISUAL INSPECTION OF THE RETURNED SPINDLE AND AN ACTUATOR FROM A 101-SERIES 12 MM IMPLANT OF LOT NUMBER 800330 REVEALED COMPONENTS OF THE IMPLANT CLEARLY SUGGESTED THAT THE SPINDLE CAP WAS COMPLETELY SHEARED OFF FROM THE IMPLANT BODY. SINCE ONLY RETRIEVED COMPONENTS WERE RETURNED, NO FUNCTIONAL TESTING COULD BE PERFORMED. THE DAMAGE TO THE IMPLANT INDICATES FAILURE LIKELY DUE TO A COMBINATION OF DEPLOYMENT AGAINST RESISTANCE, E.G. BONE, AND PHYSICIAN FAILING TO CORRECTLY ATTACH THE INSERTER TO THE SPACER. INVESTIGATION CONCLUSION: THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENT OF THE TOP OF THE SPACER IMPLANT COMING OFF DURING IMPLANT PROCEDURE WAS CONFIRMED THROUGH DEVICE ANALYSIS THEREFORE THE MOST PROBABLE ROOT CAUSE IS TRACED TO UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE TOP OF THE SPACER IMPLANT CAME OFF. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE SPACER AND WAS UNABLE TO SUCCESSFULLY. TO AVOID POSSIBLE ADDITIONAL COMPLICATION, HE DECIDED TO LEAVE THE SPACER IN PLACE. THE PATIENT WAS DOING WELL POST OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE TOP OF THE SPACER IMPLANT CAME OFF. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE SPACER AND WAS UNABLE TO SUCCESSFULLY. TO AVOID POSSIBLE ADDITIONAL COMPLICATION, HE DECIDED TO LEAVE THE SPACER IN PLACE. THE PATIENT WAS DOING WELL POST OPERATIVELY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE TOP OF THE SPACER IMPLANT CAME OFF. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE SPACER AND WAS UNABLE TO SUCCESSFULLY. TO AVOID POSSIBLE ADDITIONAL COMPLICATION, HE DECIDED TO LEAVE THE SPACER IN PLACE. THE PATIENT WAS DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874489 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO VERTIFLEX INC. 101-9812 800330 00884662000543

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention