BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ADR

    MDR report key: 7422483 · Received April 11, 2018

    Report

    Report Number
    1526439-2018-50343
    Event Type
    Injury
    Date Received
    April 11, 2018
    Date of Event
    January 1, 2017
    Report Date
    March 16, 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

    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: HIGHER REOPERATION RATE FOLLOWING CERVICAL DISC REPLACEMENT IN A RETROSPECTIVE, LONG-TERM COMPARATIVE STUDY OF 715 PATIENTS. MARTIN SKEPPHOLM, THOMAS HENRIQUES, TYCHO TULLBERG EUR SPINE J (2017) 26:2434¿2440. RECEIVED: 8 APRIL 2017 / REVISED: 27 JUNE 2017 / ACCEPTED: 11 JULY 2017 / PUBLISHED ONLINE: 17 JULY 2017. N=1: SUBSIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266533 UNKNOWN ADR UNKNOWN KWQ MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other