BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 10492215 · Received September 3, 2020

    Report

    Report Number
    3006630150-2020-03921
    Event Type
    Injury
    Date Received
    September 3, 2020
    Date of Event
    August 10, 2020
    Report Date
    September 25, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL 101-9812, LOT NUMBER 800242. THE RETURNED IMPLANT WAS ANALYZED, AND A VISUAL EXAMINATION NOTED THAT IT HAD CLEARLY SUFFERED SIGNIFICANT DAMAGE, I.E., THE RIGHT WING OF THE SUPERIOR CAM-LOBE WAS SIGNIFICANTLY BENT TOWARDS THE MEDIAN LINE. HOWEVER, THE IMPLANT FUNCTIONED ACCEPTABLY UPON FUNCTIONAL TESTING. THE DAMAGE TO IMPLANT INDICATES FAILURE LIKELY DUE TO FORCED DEPLOYMENT AGAINST A RIGID OBSTRUCTION (SPINOUS PROCESS). IT TAKES SIGNIFICANT EFFORT TO DEFORM THE TITANIUM ALLOY, WHICH SUGGESTS THAT THE USER EXERTED EXCESSIVE FORCE ATTEMPTING TO DEPLOY THE IMPLANT, ENOUGH TO CAUSE DEFORMATION OF THE CAM-LOBE. MODEL 102-9800, LOT 203925. THE RETURNED INSERTER WAS ANALYZED. UPON SUBJECTING IT TO VISUAL AND FUNCTIONAL EXAMINATION, NO DEFECTS COULD BE CONFIRMED AS THE INSERTER WAS COMPLETELY INTACT AND FUNCTIONED ACCEPTABLY. IT WAS ABLE TO COMPLETELY PASS THROUGH CANNULA AND ENGAGED/DISENGAGED WITH THE TEST IMPLANT WITHOUT ANY RESISTANCE. MODEL 101-9812, LOT 800242. THE RETURNED IMPLANT WAS SUBJECTED TO VISUAL AND FUNCTIONAL EXAMINATION. NO DEFECTS COULD BE CONFIRMED AS THE IMPLANT WAS COMPLETELY INTACT AND FUNCTIONED ACCEPTABLY. THE CAM LOBES DEPLOYED WITHOUT ANY RESISTANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE PHYSICIAN HAD A DIFFICULT CASE WHERE THE PATIENT HAD OFFSET SPINOUS PROCESSES AND A TWISTED SPINE. IT WAS NOTED THAT THE PATIENT HAD THICK BONE CAUSING RESISTANCE. THE PHYSICIAN ATTEMPTED TO DEPLOY THE SPACER IN THE L4-5 SPACE HOWEVER DURING THE SAGITTAL WIGGLE IT BENT THE SPACER AND INSERTER. THE PHYSICIAN DID NOT USE EXCESSIVE FORCE. ANOTHER SPACER WAS USED WHICH THEY IMPLANTED WITH NO PROBLEM. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY A SPACER AT L3-4 THE PATIENT HAD WHAT LOOKED LIKE A SPINOUS PROCESS FRACTURE SO THE PHYSICIAN ABORTED AT THAT LEVEL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE DEVICES WILL BE RETURNED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICES WERE RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT DEVICES: MODEL 102-9800, SUPERION IDS KIT, LOT # 203925. MODEL 101-9812 , SUPERION IDS 12MM, LOT # 800242.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE PHYSICIAN HAD A DIFFICULT CASE WHERE THE PATIENT HAD OFFSET SPINOUS PROCESSES AND A TWISTED SPINE. IT WAS NOTED THAT THE PATIENT HAD THICK BONE CAUSING RESISTANCE. THE PHYSICIAN ATTEMPTED TO DEPLOY THE SPACER IN THE L4-5 SPACE HOWEVER DURING THE SAGITTAL WIGGLE IT BENT THE SPACER AND INSERTER. THE PHYSICIAN DID NOT USE EXCESSIVE FORCE. ANOTHER SPACER WAS USED WHICH THEY IMPLANTED WITH NO PROBLEM. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY A SPACER AT L3-4 THE PATIENT HAD WHAT LOOKED LIKE A SPINOUS PROCESS FRACTURE SO THE PHYSICIAN ABORTED AT THAT LEVEL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE DEVICES WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956486 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO VERTIFLEX INC. 101-9812 800242 00884662000543

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other