BEUDAMED
    FDA Adverse Event Death Summary report: N

    SKY 2 LEVEL PLTE 34MM TI

    MDR report key: 7642897 · Received June 27, 2018

    Report

    Report Number
    1526439-2018-50596
    Event Type
    Death
    Date Received
    June 27, 2018
    Date of Event
    January 1, 2018
    Report Date
    June 6, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    KWQ
    UDI-DI
    10705034133690
    PMA / PMN Number
    K052552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER CAREGIVERS

    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

    VIVIGEN: IT WAS REPORTED THAT AN ADVERSE EVENT OF CARDIAC ARREST AND DEATH REPORTED STUDY SUBJECT (B)(6). CONCOMITANT DEVICES: VIVIGEN POUCH, BL-1500-001, LOT# 1811201-8019, QTY 2 (STRYKER) BIO AVS C-OPEN 4=14(W) X 12(D), 77101074, LOT# 1715826-1049 AND 1618761-1048.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486109 SKY 2 LEVEL PLTE 34MM TI APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDOS INTERNATIONAL SàRL CH 186802034 10705034133690

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death