BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTECURE WITH CCC

    MDR report key: 3766823 · Received April 11, 2014

    Report

    Report Number
    1038671-2014-00121
    Event Type
    Other
    Date Received
    April 11, 2014
    Date of Event
    March 3, 2014
    Report Date
    April 11, 2014
    Manufacturer
    EXACTECH INC.
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED HAS NOT BE DETERMINED AS THE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    AT FIVE MONTHS FOLLOW UP, THE SURGEON REPORTED THAT THE RESULTS OF A CBCT SHOWED NO INTEGRATION OF THE BONE GRAFT IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225519 OPTECURE WITH CCC BONE VOID FILLER MQV EXACTECH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other