BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRO OSTEON 200R

    MDR report key: 940675 · Received November 9, 2007

    Report

    Report Number
    2242816-2007-00053
    Event Type
    Injury
    Date Received
    November 9, 2007
    Date of Event
    October 16, 2007
    Report Date
    October 16, 2007
    Manufacturer
    EBI
    Product Code
    MQV
    PMA / PMN Number
    K000515
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF PRODUCT COMPLAINT HISTORY FROM 2005 TO PRESENT SHOWS NO OTHER REPORTED COMPLAINTS OF THIS NATURE FOR PRO OSTEON.

    Description of Event or Problem · 1

    SURGEON REPORTED PT DEVELOPED GIANT CELL REACTION IN AREAS WHERE GRAFT WAS USED. REVISION SURGERY SCHEDULED TO REGRAFT AFFECTED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO OSTEON 200R MQV EBI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention