BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERIGRAFT PUTTY 1CC

    MDR report key: 1368838 · Received April 23, 2009

    Report

    Report Number
    3004155681-2009-00001
    Event Type
    Other
    Date Received
    April 23, 2009
    Date of Event
    April 6, 2009
    Report Date
    April 7, 2009
    Manufacturer
    THERICS, LLC
    Product Code
    MQV
    PMA / PMN Number
    K053228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN IMPLANTED, HENCE CANNOT BE EVALUATED.

    Description of Event or Problem · 1

    EXPIRED MATERIAL IMPLANTED INTO PT IN 2009. THE PRODUCT WAS USED PAST ITS EXPIRATION DATE OF MARCH 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERIGRAFT PUTTY 1CC BONE VOID FILLER MQV THERICS, LLC 0107010 A07C02C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other