BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC SPINAL SYSTEM

    MDR report key: 1604699 · Received February 5, 2010

    Report

    Report Number
    3004893332-2010-00001
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    January 6, 2010
    Report Date
    February 5, 2010
    Manufacturer
    SPINAL ELEMENTS
    Product Code
    ODP
    PMA / PMN Number
    K078133
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED AND EVALUATED UNDER RMA NUMBER (B) (4) ON 1/20/2010 AND 2/1/2010. A SPRING LOADED AWL AND SCREW WERE INTRODUCED TO THE IMPLANT TO EVALUATE FUNCTIONALITY OF THE INSERT AND LOCKING MECHANISMS. THE INSERT AND THE LOCKING MECHANISM WERE INTACT AND FUNCTIONAL. RMA PHOTOS WERE TAKEN. RESULTS: THE PATIENT DID NOT DO ANY POST-OP FOLLOW-OP. CONCLUSIONS: THE PATIENT HAD POOR BONE QUALITY. THE COMPLAINANT REPORTED THAT THIS FAILURE WAS CAUSED BY THE PATIENT'S POOR BONE QUALITY AND THAT SPINAL ELEMENTS' DEVICES DID NOT FAIL TO PERFORM IN ANY WAY.

    Description of Event or Problem · 1

    PATIENT COMPLAINED OF PAIN WHEN SWALLOWING POST-OP. THE ATTENDING PHYSICIAN OBSERVED ONE SCREW PUSHING OUT OF THE RIGHT SIDE OF THE IMPLANT ON FILMS THAT WERE IMPLANTED ON (B) (6) 2009. A REVISION WAS DETERMINED TO BE REQUIRED. A REVISION SURGERY WAS PERFORMED ON (B) (6) 2010, TO REPLACE IMPLANT. THE REVISION CASE WAS COMPLETED WITH NO FURTHER INCIDENCES. THE PATIENT IS REPORTED TO BE IN GOOD HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSAIC SPINAL SYSTEM ODP SPINAL ELEMENTS 51412-307 070454

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention