BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LUMBAR EXTENSION SIZE 10/220MM RADIUS

    MDR report key: 1903416 · Received November 15, 2010

    Report

    Report Number
    2530088-2010-00182
    Event Type
    Injury
    Date Received
    November 15, 2010
    Report Date
    October 19, 2010
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MDI
    PMA / PMN Number
    H030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. IMPLANT DATE REPORTED AS 5-6 YEARS AGO. INVESTIGATION IS ONGOING. NO CONCLUSION CAN BE DRAWN AT THIS TIME. MANUFACTURE DATE CANNOT BE DETERMINED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PATIENT IMPLANTED WITH A VEPTR CONSTRUCT 5-6 YEARS AGO WAS RETURNED TO THE OPERATING ROOM IN (B)(6), 2010 DUE TO A BROKEN TI LUMBAR EXTENSION SIZE 10/220MM RADIUS. THE EXTENSION BROKE AT THE INTERFACE OF THE ROUND LOWER PORTION AND THE SQUARE UPPER PORTION. THE SURGEON REMOVED THE UPPER PORTION OF THE EXTENSION, ATTACHED A NEW EXTENSION WITH A DOMINO CONNECTOR AND EXTENDED THE UPPER PORTION INTO THE EXISTING RIB SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI LUMBAR EXTENSION SIZE 10/220MM RADIUS VEPTR IMPLANT MDI SYNTHES BRANDYWINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention