BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CAGE/SPACER

    MDR report key: 7751597 · Received August 6, 2018

    Report

    Report Number
    1526439-2018-50734
    Event Type
    Injury
    Date Received
    August 6, 2018
    Report Date
    July 9, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MQP
    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: ANTERIOR CONTROLLABLE ANTEDISPLACEMENT FUSION (ACAF) FOR SEVERE CERVICAL OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT: COMPARISON WITH ANTERIOR CERVICAL CORPECTOMY WITH FUSION (ACCF) HAISONG YANG, JINGCHUAN SUN, JIANGANG SHI, GUODONG SHI, YONGFEI GUO, YONG YANG. RECEIVED 15 DECEMBER 2017; ACCEPTED 10 APRIL 2018. N=2: CAGE SUBSIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594510 UNKNOWN CAGE/SPACER UNKNOWN MQP MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other