BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 1880297 · Received October 19, 2010

    Report

    Report Number
    1000165971-2010-00953
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 8, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    CONNECTION ISSUES DURING THE IMPLANTATION PROCEDURE WERE REPORTED; THEREFORE, THE DEVICE WAS NOT IMPLANTED. REPORTEDLY, TWO SCREWDRIVERS WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA CRM S.R.L. REPLY SR 2370

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention