BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CAGE/SPACER

    MDR report key: 8939395 · Received August 28, 2019

    Report

    Report Number
    1526439-2019-52057
    Event Type
    Injury
    Date Received
    August 28, 2019
    Report Date
    August 16, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> (B)(4).

    Description of Event or Problem · 1

    A LITERATURE ARTICLE WAS REVIEWED: "ANTERIOR HYBRID DECOMPRESSION AND SEGMENTAL FIXATION FOR ADJACENT THREE-LEVEL CERVICAL SPONDYLOSIS". QUNFENG GUO ¿ BIN NI ¿ FENGJIN ZHOU ¿ XUHUA LU ¿ JIAN YANG ¿ JINSHUI CHEN ¿ YANG YU ¿ LIANG ZHU ARCH ORTHOP TRAUMA SURG (2011) 131:631¿636. N=5 MESH CAGE SUBSIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734104 UNKNOWN CAGE/SPACER UNKNOWN MAX MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other