BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVUE

    MDR report key: 9056585 · Received September 14, 2019

    Report

    Report Number
    3005977257-2019-00012
    Event Type
    Malfunction
    Date Received
    September 14, 2019
    Date of Event
    August 16, 2019
    Report Date
    September 13, 2019
    Manufacturer
    SPINEFRONTIER INC
    Product Code
    KWQ
    UDI-DI
    00190361002130
    PMA / PMN Number
    K121060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SCREW INVOLVED IN THIS COMPLAINT WAS SUCCESSFULLY IMPLANTED, DESPITE THE THIN STRIP OF THE SCREW THREADS RUBBING OFF THE PLATE DURING INSERTION. THIS PRECLUDED EVALUATION OF THE ACTUAL SAMPLE. SPINEFRONTIER INVESTIGATION DETERMINED THIS WAS AN EXTREME LORDOSIS CASE WHICH REQUIRED BENDING THE PLATE TO FIXATE IT AND SCREW CONSTRUCT ONTO THE VERTEBRAL BODY. THE EXTREME ANGULATION CAUSED THE SCREW ANGLE OF INSERTION TO BE OUTSIDE OF THE RECOMMENDED 14° VARIABLE SCREW ANGULATION. WHEN THIS OCCURRED, IT CAUSED AN UNDESIRED RUBBING OF THE SCREW ON THE PLATE DURING INSERTION. THE THIN FLEXIBLE STRIP OF THE SCREW THREAD WAS REMOVED FROM THE SITE. THIS EVENT DID NOT CAUSE HARM TO THE PATIENT AND THE INTEGRITY OF THE CONSTRUCT WAS NOT COMPROMISED BY THIS EVENT. A REVIEW OF THE INVUE MAX + INSET ANTERIOR CERVICAL PLATE DFMEA DETERMINED THAT THIS FAILURE MODE SHEARING OF "METAL" WAS IDENTIFIED DURING THE DESIGN VERIFICATION TESTING, AND THE RISKS WERE ADEQUATELY MITIGATED IN RISK HAZARD ANALYSIS. COMPLAINT VS SALES TRENDING IDENTIFIED SEVEN (7) COMPLAINTS (INCLUDING THIS OCCURRENCE) OF THIS ISSUE. THIS OCCURRENCE LEVEL WAS CALCULATED AT (B)(4), WHICH IS A LOWER OCCURRENCE THAN THE RANGE SPECIFIED BY THE RISK HAZARD ANALYSIS (B)(4) (IMPROBABLE). THEREFORE, NO RISK DOCUMENT DOES NOT NEED TO BE UPDATED IN RESPONSE TO THIS COMPLAINT. A REVIEW OF THE INVUE MAX + INSET ANTERIOR CERVICAL PLATE IFU-71-00001 AND SURGICAL TECHNIQUE ST-71-00001 SHOWED BOTH INCLUDE A WARNING OF SHEARING IN THE WARNINGS AND PRECAUTIONS SECTIONS.

    Description of Event or Problem · 1

    SPINEFRONTIER SALES REPRESENTATIVE REPORTED THAT DURING EXTREME, 4 LEVEL LORDOSIS CASE, THE SURGEON HAD TO BEND THE INVUE PLATE TO CONFORM TO THE EXTREME (C5 - C7) LORDOSIS. THE ANGULATION OF THE SCREW WAS GREATER THAN THE RECOMMENDED 14° VARIABLE SCREW ANGULATION OUTLINED IN THE SURGICAL TECHNIQUE. THE EXTREME ANGULATION LED TO A THIN FLEXIBLE STRIP OF THE SCREW THREADS WAS RUBBED OFF BY THE PLATE. THE SURGEON REMOVED THE THIN PIECE OF METAL FROM THE SURGICAL SITE AND COMPLETED THE CASE WITHOUT ANY COMPLICATIONS OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852239 INVUE INVUE KWQ SPINEFRONTIER INC IM71059-03 EG16 00190361002130

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention