BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDUS ANTERIOR CERVICAL PLATE SYSTEM,

    MDR report key: 7616847 · Received June 19, 2018

    Report

    Report Number
    3005977257-2018-00002
    Event Type
    Malfunction
    Date Received
    June 19, 2018
    Date of Event
    May 18, 2018
    Report Date
    June 19, 2018
    Manufacturer
    SPINEFRONTIER, INC
    Product Code
    KWQ
    UDI-DI
    00190361002130
    PMA / PMN Number
    K093776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED INCIDENT WAS CONFIRMED BASED ON THE FOLLOWING: EVALUATION OF AN IMAGE SUPPLIED BY THE END USER, EVALUATION OF THE ACTUAL SAMPLE UNDER MAGNIFICATION AND DESIGN OF AN EXPERIMENT TO REPLICATE THE REPORTED FAILURE WHICH FOCUSED ON INSERTING A SCREW AT A STEEP ANGLE (NOT IN LINE WITH THE TRAJECTORY OF THE PILOT HOLE). A REVIEW OF THE DFMEA DETERMINE THAT THIS FAILURE MODE SHEARING OF "DEBRIS (METAL)" WAS IDENTIFIED DURING THE DESIGN VERIFICATION TESTING, AND THE RISKS WERE ADEQUATELY MITIGATED IN RISK HAZARD ANALYSIS. COMPLAINT VS SALES TRENDING IDENTIFIED (B)(4) OTHER COMPLAINTS RELATING TO THE SHEARING OF THE INVUE SCREWS (B)(4). THIS OCCURRENCE LEVEL IS A LOWER OCCURRENCE THAN THE RANGE SPECIFIED BY THE RISK HAZARD ANALYSIS THEREFORE NO RISK DOCUMENT DOES NOT NEED TO BE UPDATED IN RESPONSE TO THIS COMPLAINT. PLACING THE SCREW AT AN ANGLE OUTSIDE OF THE 14 DEGREES RECOMMENDATION WAS CITED AS THE ROOT CAUSE OF THIS OCCURRENCE, THIS IS CONSIDERED OFF LABEL USE. HOWEVER, A REVIEW OF INVUE MAX LABELING: IFU-71-00001 INVUE MAX IFU AND ST-71-00001 INVUE MAX SURGICAL TECHNIQUE, DETERMINED THAT UPDATES ARE REQUIRED TO INCLUDE SHEARING OF THE SCREW IN THE WARNINGS AND PRECAUTIONS SECTIONS.

    Description of Event or Problem · 1

    SPINEFRONTIER RECEIVED INFORMATION FORM A CLINICIAN STATING THAT METAL STRIPS SHEARED OFF THE THREADS OF THE LEFT C7 SCREW DUE TO THE SEVERE ANGLE BETWEEN THE PLATE AND THE SCREW. THE SHARED SCREW WAS REMOVED AND REPLACED WITH A NEW ONE, IT WAS REPORTED THAT THE NEW SCREW SHEARED IN THE SAME MANNER AS THE FIRST, THE SECOND SCREW WAS LEFT IN-PLACE. THIS INCIDENT OCCURRED DURING A C6 -C7 POSTERIOR DECOMPRESSION AND FUSION CASE ON (B)(6) MALE PATIENT FOLLOWING A SEVERE MVA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456697 INDUS ANTERIOR CERVICAL PLATE SYSTEM, INDUS ANTERIOR CERVICAL PLATE SYSTEM KWQ SPINEFRONTIER, INC IM71059-03 DL10 00190361002130

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening