BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT

    MDR report key: 1936266 · Received December 15, 2010

    Report

    Report Number
    1000165971-2010-01026
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    November 5, 2010
    Report Date
    December 9, 2010
    Manufacturer
    SORIN BIOMEDICA C.R.M., S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONNECTION ISSUES DURING THE IMPLANTATION PROCEDURE; THEREFORE, THE DEVICE WAS NOT IMPLANTED. THE PHYSICIAN STATES THAT HE HAD THE SCREWDRIVER PERPENDICULAR TO THE SETSCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPRIT NVZ SORIN BIOMEDICA C.R.M., S.R.L. ESPRIT SR 2442

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention