BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENOVIS

    MDR report key: 8204398 · Received December 28, 2018

    Report

    Report Number
    3007932279-2018-00003
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    November 29, 2018
    Report Date
    December 27, 2018
    Manufacturer
    RENOVIS SURGICAL TECHNOLOGIES
    Product Code
    OVE
    UDI-DI
    00841523118090
    PMA / PMN Number
    K153250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS REPORTED AFTER ROUTINE FOLLOW-UP EXAMINATION AT 2 MONTHS (DATE OF SURGERY: (B)(6) 2018, DATE OF OCCURRENCE: (B)(6) 2018). AN X-RAY OF THE PATIENT TAKEN DURING THE ROUTINE FOLLOW-UP SHOWS THAT THE LOWER COVER PLATE HAS FRACTURED INTO 5 PIECES. THE PHYSICIAN STATED THAT THE PATIENT WAS ASYMPTOMATIC, AND NO REVISION SURGERY WAS NEEDED DUE TO THE FRACTURED COVER PLATE. USING THE FOLLOW-UP X-RAY AS A GUIDE, SOLIDWORKS WAS USED TO RECREATE THE CURRENT CONDITION OF THE SUPERIOR BOTH CONSTRUCTS. FROM THE RECREATION OF THE CONSTRUCT, THE FOLLOWING INFORMATION CAN BE GATHERED ABOUT THE BOTTOM CONSTRUCT: SURGERY WAS PERFORMED ON TWO LEVELS FROM C3-C5. THE CERVICAL SYSTEM IFU STATES IN THE INDICATIONS FOR USE THAT THE "...SYSTEM IS INDICATED FOR INTERVERTEBRAL FUSION PROCEDURES... AT ONE LEVEL FROM C2-T1". FOR LEVEL C3-C4 THE CONSTRUCT IS ORIENTED 2DOWN/1UP (THE TWO LATERAL SCREWS WERE INSERTED INTO THE INFERIOR VERTEBRA WHILE THE CENTER SCREW WAS INSERTED INTO THE SUPERIOR VERTEBRA). FOR LEVEL C4-C5 THE CONSTRUCT IS ORIENTED 2DOWN/1UP. THE PLATE HAS FRACTURED INTO APPROXIMATELY 5 PIECES. THE CENTER SCREW HAS TRANSLATED APPROXIMATELY 0.85MM. THE CENTER SCREW ANGLE IS SHALLOW BY APPROXIMATELY 17°. THE SCREWS USED IN THE LOWER CONSTRUCT ARE ALL 14MM IN LENGTH. THE TWO 12MM SCREWS LISTED IN THE COMPLAINT WERE USED ON THE UPPER CONSTRUCT. A REVIEW OF MANUFACTURING RECORDS SHOW THERE WERE NO DISCREPANCIES OR DEVIATIONS FOR THE LOT OF ASSOCIATED IMPLANTS. A ROOT CAUSE ANALYSIS WAS PERFORMED AND IT WAS DETERMINED THAT THE MOST LIKELY CAUSE FOR THE FAILURE MECHANISM IS THE CENTER SCREW PUSHING ON THE COVER PLATE UNTIL IT FRACTURED. THIS FAILURE MECHANISM IS IDENTIFIED IN THE CORE RISK DOCUMENT FOR THIS SYSTEM. RENOVIS WILL CONTINUE TO MONITOR AND TREND FOR SIMILAR COMPLAINTS. CORRECTIVE ACTION WILL BE TAKEN IN THE FUTURE IF DEEMED NECESSARY.

    Description of Event or Problem · 1

    DURING A ROUTINE 2-MONTH FOLLOW-UP VISIT, THE SURGEON WAS REVIEWING PATIENT X-RAYS AND DISCOVERED THAT THE COVER PLATE ON A CERVICAL CAGE IMPLANT HAD BECOME DISLODGED AND FRACTURED. THE SURGEON STATED THAT THE PATIENT WAS ASYMPTOMATIC AND NO REVISION SURGERY WAS REQUIRED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044282 RENOVIS SA CERVICAL COVER PLATE, NITINOL OVE RENOVIS SURGICAL TECHNOLOGIES 100987-1 00841523118090

    Patients

    Seq Age Sex Outcome Treatment
    1