BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S 150 STAND-ALONE ANTERIOR CERVICAL INTERBODY FUSION

    MDR report key: 6426074 · Received March 22, 2017

    Report

    Report Number
    3007932279-2017-00001
    Event Type
    Malfunction
    Date Received
    March 22, 2017
    Date of Event
    February 23, 2017
    Report Date
    March 22, 2017
    Manufacturer
    RENOVIS SURGICAL TECHNOLOGIES, INC.
    Product Code
    OVE
    UDI-DI
    00841523118250
    PMA / PMN Number
    K153250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS REPORTED TO RENOVIS AFTER A ROUTINE 6-MONTH FOLLOW-UP EXAMINATION. AND X-RAY REVEALED A DISLODGED COVER PLATE AND TWO BACKED-OUT SCREWS. ACCORDING TO THE SURGEON, THE PATIENT IS ASYMPTOMATIC AND THE AFFECTED LEVEL OF THE 3 LEVEL CONSTRUCT HAVE FUSED. THERE ARE NO CURRENT PLANS TO RE-OPERATE AS THE COVER PLATE APPEARS FULLY CAPTURED IN THE DISC SPACE. THIS COMPLAINT WILL BE RE-OPENED IF/WHEN RENOVIS RECEIVES INFORMATION THAT A REVISION SURGERY IS PLANNED OR HAS BEEN PERFORMED. AS NO REVISION SURGERY HAS BEEN PLANNED, RENOVIS WILL NOT RECEIVE THE IMPLANTS BACK FOR A FULL INVESTIGATION. BASED ON THE INITIAL ANALYSIS, THE MOST LIKELY CAUSE FOR THE FAILURE MECHANISM IS ONE OR BOTH OF THE OUTBOARD SCREWS PUSHING ON AND DISLODGING THE COVER PLATE DUE TO EXCESSIVE FORCES PLACED ON THE MOST INFERIOR CAGE OF A 3 LEVEL FUSION. DEVICE NOT EXPLANTED.

    Description of Event or Problem · 1

    SALES REP FOR S1 SPINE (GL) INFORMED RENOVIS CUSTOMER SERVICE (KJ) OF A PRODUCT COMPLAINT ON 02/23/2017. THE COMPLAINT PERTAINS TO A S150 STAND-ALONE ANTERIOR CERVICAL INTERBODY FUSION 3-LEVEL CONSTRUCT, WHICH IS A CONTRAINDICATION TO THE IFU. THE COMPLAINT WAS REPORTED TO RENOVIS AFTER A ROUTINE 6-MONTH FOLLOW-UP EXAMINATION. AN X-RAY REVEALED A DISLODGED COVER PLATE AND TWO BACKED-OUT SCREWS ON THE MOST INFERIOR CAGE OF A 3-LEVEL FUSION. ACCORDING TO THE SURGEON, THE PATIENT IS ASYMPTOMATIC AND ALL 3 LEVELS HAVE FUSED. THERE ARE NO CURRENT PLANS TO RE-OPERATE AS THE COVER PLATE APPEARS FULLY CAPTURED IN THE DISC SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208055 S 150 STAND-ALONE ANTERIOR CERVICAL INTERBODY FUSION INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL OVE RENOVIS SURGICAL TECHNOLOGIES, INC. S 150 3296-8 00841523118250

    Patients

    Seq Age Sex Outcome Treatment
    1