BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI VEPTR ADAPTER

    MDR report key: 1905795 · Received November 19, 2010

    Report

    Report Number
    2530088-2010-00211
    Event Type
    Injury
    Date Received
    November 19, 2010
    Report Date
    November 9, 2010
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MDI
    PMA / PMN Number
    H03009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION IS ON GOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED A FALL AND BREAKAGE OF THE VEPTR ADAPTER WHERE IT CONNECTS TO THE VEPTR I RIB CONSTRUCT WAS NOTED. SURGEON REVISED THE VEPTR I/VEPTR II CONSTRUCT WITH ANOTHER VEPTR II ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI VEPTR ADAPTER VEPTR ADAPTER MDI SYNTHES BRANDYWINE NA 6056908

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention VEPTR RIB CONSTRUCT