BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITOSS BONE GRAFT SUBSTITUTE

    MDR report key: 2585543 · Received May 18, 2012

    Report

    Report Number
    2530131-2012-00010
    Event Type
    Injury
    Date Received
    May 18, 2012
    Report Date
    May 16, 2012
    Manufacturer
    ORTHOVITA, INC.
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK WHICH SUBSET OF VITOSS WAS USED IN HIS PROCEDURE OR WHICH LOT NUMBER OF DEVICE WAS USED, THEREFORE, NO DEVICE HISTORY REVIEW COULD BE COMPLETED. AS NO INFECTION WAS CONFIRMED, IT IS CONCEIVABLE THAT INFLAMMATION WAS DEVICE OR PROCEDURE RELATED RATHER THAN INFECTION RELATED. WHILE NO WIDELY REPORTED, INFLAMMATION AROUND THE DEVICE SITE HAS BEEN NOTED IN THE PAST. NO INFECTION HAS EVER BEEN CAUSALLY RELATED WITH VITOSS. IT IS UNK WHETHER THIS ADVERSE EVENT IS DEVICE RELATED. SHOULD ANY FURTHER INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS TREATED WITH 20 ML OF THE DEVICE WITHIN THE FRAME OF REMOVAL OF A HUMERUS CYST. IN ADDITION, AN OSTEOSYNTHESIS PLATE HAD BEEN USED FOR STABILIZATION. TWO WEEKS AFTER SURGERY, THE PT DEVELOPED FEVER AND MOISTURE IN THE AREA OF SURGERY. THE CRP VALUE WAS INCREASED BUT THERE WERE NO OTHER SIGNS FOR INFECTION. BECAUSE THERE WAS NO IMPROVEMENT OF SYMPTOMS, THE DEVICE WAS EXPLANTED. THE PT WAS SYMPTOM FREE AFTER DEVICE REMOVAL. IT SHOULD BE NOTED THAT THIS PROCEDURE WAS PERFORMED OUTSIDE OF THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITOSS BONE GRAFT SUBSTITUTE FILLER, BONE VOID, CALCIUM COMPOUND MQV ORTHOVITA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R