BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 954734 · Received November 27, 2007

    Report

    Report Number
    2242816-2007-00063
    Event Type
    Injury
    Date Received
    November 27, 2007
    Date of Event
    October 8, 2007
    Report Date
    November 15, 2007
    Manufacturer
    EBI
    Product Code
    KWQ
    PMA / PMN Number
    K023133
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT LABELING INDICATES NON UNION (PSEUDARTHROSES) AND FRACTURE OF THE IMPLANT AS POSSIBLE ADVERSE EFFECTS. PRODUCT LABELING (WARNINGS) ALSO INDICATES THAT DEVICES ARE NOT DESIGNED TO WITHSTAND THE UNSUPPORTED STRESS OF FULL WEIGHT BEARING OR LOAD BEARING, AND CANNOT WITHSTAND ACTIVITY LEVELS AND/OR LOADS EQUAL TO THOSE PLACED ON NORMAL HEALTHY BONE. IF HEALING IS DELAYED OR DOES NOT OCCUR, THE IMPLANT COULD EVENTUALLY BREAK DUE TO METAL FATIGUE.

    Description of Event or Problem · 1

    SPINAL SURGERY PERFORMED IN 2006. NON-FUSION AND BROKEN SCREWS WERE OBSERVED. REVISION SURGERY PERFORMED 2007, TO REPLACE PLATE AND SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM KWQ EBI PL332C

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention