BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 11287986 · Received February 5, 2021

    Report

    Report Number
    3006630150-2021-00320
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    January 12, 2021
    Report Date
    March 12, 2021
    Manufacturer
    VERTIFLEX INC.
    Product Code
    NQO
    UDI-DI
    00884662000543
    PMA / PMN Number
    P140004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL 101-9812, LOT 800262. THE RETURNED IMPLANT WAS ANALYZED AND THE COMPLAINT OF THE IMPLANT BEING STRIPPED WAS CONFIRMED. THE SPINDLE CAP WAS COMPLETELY SHEARED OFF FROM THE IMPLANT BODY. THE DAMAGE TO IMPLANT INDICATES THE FAILURE WAS DUE TO A COMBINATION OF DEPLOYMENT AGAINST RESISTANCE, FOR EXAMPLE, BONE, AND THE PHYSICIAN FAILING TO CORRECTLY ATTACH THE INSERTER TO THE SPACER. MODEL 101-9812, LOT 700091. THE RETURNED IMPLANT WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE PATIENT HAD A VERY THICK SPINOUS PROCESS SPACE AT L4-5, AND UPON ATTEMPTING TO DEPLOY A 12MM IMPLANT, THE IMPLANT GOT HUNG UP AND WAS STRIPPED. THE PHYSICIAN REMOVED THE IMPLANT AND ATTEMPTED USING A NEW 12MM IMPLANT, HOWEVER ONCE AGAIN THE IMPLANT COULD NOT PASS AROUND THE SPINOUS PROCESS SPACE. THE PHYSICIAN DECIDED IT WAS BEST TO ABORT THE CASE. THE PATIENT IS DOING WELL POST-OPERATIVELY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SUPERION IMPLANT, UPN: (B)(4), MODEL: 101-9812, LOT: 700091, BATCH: 700091.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE PATIENT HAD A VERY THICK SPINOUS PROCESS SPACE AT L4 5, AND UPON ATTEMPTING TO DEPLOY A 12MM IMPLANT, THE IMPLANT GOT HUNG UP AND WAS STRIPPED. THE PHYSICIAN REMOVED THE IMPLANT AND ATTEMPTED USING A NEW 12MM IMPLANT, HOWEVER ONCE AGAIN THE IMPLANT COULD NOT PASS AROUND THE SPINOUS PROCESS SPACE. THE PHYSICIAN DECIDED IT WAS BEST TO ABORT THE CASE. THE PATIENT IS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182132 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO VERTIFLEX INC. 101-9812 800262 00884662000543

    Patients

    Seq Age Sex Outcome Treatment
    1 Other