BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMEGA 21 SYSTEM

    MDR report key: 3002838 · Received March 13, 2013

    Report

    Report Number
    0009610576-2013-00005
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    December 20, 2012
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    MNH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT WAS RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. A CAPA DETERMINATION HAS BEEN INITIATED BY BIOMET GERMANY RELATED TO THE LATE REPORTING OF THIS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT'S FAMILY'S LEGAL COUNSEL THAT PATIENT UNDERWENT PRIMARY SPINAL SURGERY ON (B)(6) 2009. LEGAL COUNSEL REPORTS THAT PATIENT ALLEGEDLY DEVELOPED AN INFECTION ON AN UNKNOWN DATE AND SUBSEQUENTLY PASSED AWAY. NO FURTHER DETAILS HAVE BEEN PROVIDED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105627 OMEGA 21 SYSTEM OMEGA 21 SPINAL SYSTEM MNH BIOMET SPAIN, S.L. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Death| H