BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZAVATION CERVICAL PLATE SYSTEM

    MDR report key: 6691037 · Received July 6, 2017

    Report

    Report Number
    3008583793-2017-00004
    Event Type
    Malfunction
    Date Received
    July 6, 2017
    Report Date
    June 7, 2017
    Manufacturer
    ZAVATION
    Product Code
    KWP
    PMA / PMN Number
    K112484
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOT AVAILABLE.

    Description of Event or Problem · 1

    SURGEON INFORMED THE REPRESENTATIVE THAT AT THE FOUR MONTH POST OPERATIVE APPOINTMENT THE X-RAY PRESENTED THAT ONE CERVICAL SCREW HAS BACKED OUT OF THE CERVICAL PLATE. INITIALLY, THE SURGEON WAS GOING TO MONITOR THE CASE DUE TO THE FACT THAT THE PATIENT PRESENTED NO ADVERSE SYMPTOMS BECAUSE OF THE MALFUNCTION. THE SURGEON LATER DECIDED TO SURGICALLY REMOVE THE SCREW ON AN UNKNOWN DATE. THE REMOVED SCREW WAS UNAVAILABLE FOR EVALUATION, NOR HAS THE IDENTIFYING LOT NUMBER(S) BEEN PROVIDED. A REVIEW OF THE DHR (DEVICE HISTORY RECORD) REVEALED NO MANUFACTURING, PROCESSING OR DESIGN RELATED IRREGULARITIES. X-RAY WERE REVIEWED BY EXPERT SURGEON, (B)(6). MD. DR. (B)(6) FOUND NO EVIDENCE OF ANY DESIGN ISSUES AND THE X-RAY DISCLOSED A HALO EFFECT WHICH DR. (B)(6) INDICATED IS INDICATIVE OF SCREW MICRO MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470192 ZAVATION CERVICAL PLATE SYSTEM CERVICAL PLATE CERVICAL SCREW KWP ZAVATION 10-XXXX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other