BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA-21 VERTEBRAL FIXATION SYSTEM

    MDR report key: 9738396 · Received February 21, 2020

    Report

    Report Number
    0009610576-2020-00001
    Event Type
    Malfunction
    Date Received
    February 21, 2020
    Report Date
    February 20, 2020
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    MNH
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). EVENT OCCURRED IN (B)(6). THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K061441. THE COMPLAINT IS GOING TO BE CLOSED DUE TO THE LACK OF INFORMATION (LOT NUMBER HAS NOT BEEN PROVIDED). THEREFORE, IT HAS NOT BEEN POSSIBLE TO PERFORM AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED ACCORDINGLY, AND SUBSEQUENTLY A SUPPLEMENTAL REPORT WILL BE PROVIDED WHERE DEEMED REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PERFORMANCE OF THE SCHEDULE PMS 20 OMEGA-21 VERTEBRAL FIXATION SYSTEM, THE SURVEY PERFORMED BY DR. (B)(6) (HOSPITAL (B)(6)) INDICATES A BREAKAGE OF THE SCREWS OF VERTEBRAL FIXATION SYSTEM. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205633 OMEGA-21 VERTEBRAL FIXATION SYSTEM SPINE PROSTHESIS MNH BIOMET SPAIN, S.L. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1