BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CAGE/SPACER

    MDR report key: 8964910 · Received September 5, 2019

    Report

    Report Number
    1526439-2019-52058
    Event Type
    Injury
    Date Received
    September 5, 2019
    Report Date
    August 16, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MAX
    UDI-DI
    0(01)AVAILABLE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). PC: SURGICAL INTERVENTION (EVEN THOUGH THERE WAS NO CONSEQUENCE TO THE PATIENT, SURGICAL INTERVENTION WAS INCLUDED AS SUBSIDENCE HAS LEAD TO THE NEED FOR SURGICAL REVISION). (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

    A LITERATURE ARTICLE WAS REVIEWED: "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 N=2 MESH CAGE SUBSIDENCE . THIS COMPLAINT INVOLVES TWO (2) DEVICES.

    Description of Event or Problem · 1

    A LITERATURE ARTICLE WAS REVIEWED: "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. N=2 MESH CAGE SUBSIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759279 UNKNOWN CAGE/SPACER UNKNOWN MAX MEDOS INTERNATIONAL SàRL CH 0(01)AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention