BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC IMPLANT SYSTEM

    MDR report key: 1672631 · Received April 30, 2010

    Report

    Report Number
    3004893332-2010-00003
    Event Type
    Injury
    Date Received
    April 30, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 29, 2010
    Manufacturer
    SPINAL ELEMENTS
    Product Code
    ODP
    PMA / PMN Number
    K071833
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN OBSERVED A SCREW BACKING OUT OF THE INITIAL IMPLANT ON FILMS. A REVISION WAS DETERMINED TO BE REQUIRED. A REVISION SURGERY WAS PERFORMED ON (B) (6) 2010 TO REMOVE MOSAIC IMPLANT AND REPLACE IMPLANT WITH ANOTHER MFR'S DEVICE. THE REVISION CASE WAS COMPLETED WITH NO FURTHER INCIDENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSAIC IMPLANT SYSTEM ODP SPINAL ELEMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention