BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZAVATION ANTERIOR CERVICAL PLATE AND SCREWS

    MDR report key: 9106253 · Received September 23, 2019

    Report

    Report Number
    3008583793-2019-00001
    Event Type
    Malfunction
    Date Received
    September 23, 2019
    Date of Event
    September 15, 2017
    Report Date
    September 6, 2019
    Manufacturer
    ZAVATION MEDICAL PRODUCTS, LLC 220 LAKELAND PARKWA
    Product Code
    KWQ
    PMA / PMN Number
    K112533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    LOCKING TAB FAILURE/SCREW BACKED OUT OF CERVICAL PLATE (2 YEARS POST-SURGERY 3 LEVEL ACDF C4-C7) IDENTIFIED BECAUSE PATIENT FELT RUBBING AGAINST HER ESOPHAGUS (ESOPHAGEAL IRRITATION) AND CONSULTED WITH SURGEON. SCREW HAD BACKED OUT APPROXIMATELY 50%-.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901797 ZAVATION ANTERIOR CERVICAL PLATE AND SCREWS CERVICAL PLATE/SCREWS/PRODUCT CODE:KWQ KWQ ZAVATION MEDICAL PRODUCTS, LLC 220 LAKELAND PARKWA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention