BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANCELLO-PURE WEDGE

    MDR report key: 1850256 · Received July 13, 2010

    Report

    Report Number
    3002719998-2010-00004
    Event Type
    Injury
    Date Received
    July 13, 2010
    Date of Event
    June 8, 2010
    Report Date
    July 13, 2010
    Manufacturer
    RTI BIOLOGICS
    Product Code
    MQV
    PMA / PMN Number
    K072327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS HAVE BEEN REQUESTED FROM THE PHYSICIAN. INVESTIGATION IN PROCESS.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PT UNDERWENT A SURGICAL PROCEDURE WHERE A CANCELLO-PURE 12MM EVANS BONE WEDGE XENOGRAFT WAS IMPLANTED. AT AN UNK DATE, THE GRAFT WAS REMOVED FOR UNK REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANCELLO-PURE WEDGE BOVINE BONE VOID FILLER MQV RTI BIOLOGICS 2-090202

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention