BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PLATES

    MDR report key: 7703880 · Received July 19, 2018

    Report

    Report Number
    1526439-2018-50698
    Event Type
    Injury
    Date Received
    July 19, 2018
    Report Date
    June 21, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: A COMPARISON OF A NEW ZERO-PROFILE, STAND-ALONE FIDJI CERVICAL CAGE AND ANTERIOR CERVICAL PLATE FOR SINGLE AND MULTILEVEL ACDF: A MINIMUM 2-YEAR FOLLOW-UP STUDY. ZHONGHAI LI1,2,3; YANTAO ZHAO1,2; JIAGUANG TANG1,2; DONGFENG REN1,2; JIDONG GUO1,2; HUADONG WANG1,2; LI LI1,2; SHUXUN HOU1,2; EUR SPINE J (2017) 26:1129¿1139. RECEIVED: 8 DECEMBER 2015/REVISED: 16 JULY 2016 / ACCEPTED: 6 AUGUST 2016 / PUBLISHED ONLINE: 23 AUGUST 2016. N=1: IMPLANT DISLODGEMENT. N=2: POST OP BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545957 UNKNOWN PLATES UNKNOWN KWQ MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other