BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITOSS BONE GRAFT SUBSTITUTE

    MDR report key: 1056094 · Received May 22, 2008

    Report

    Report Number
    2530131-2008-00001
    Event Type
    Injury
    Date Received
    May 22, 2008
    Product Code
    MQV
    PMA / PMN Number
    994337
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER EXAMINING THE AVAILABLE EVIDENCE, THE LIKELIHOOD OF ORTHOVITA'S DEVICE BEING THE CAUSATIVE AGENT IN THIS EVENT IS REMOTE. ALTHOUGH ORTHOVITA DOES NOT BELIEVE THIS EVENT IS DEVICE-RELATED, WE ARE FILING THIS REPORT FOR CLARIFICATION. THERE IS PEER-REVIEWED LITERATURE THAT SUPPORTS THE OCCURRENCE OF THESE SYMPTOMS WITH THE USE OF BMPS (SHIELDS LBE, RAQUE GH, GLASSMAN SD. ADVERSE EFFECTS ASSOCIATED WITH HIGH-DOSE RECOMBINANT HUMAN BONE MORPHOGENIC PROTIEN-2 USE IN ANTERIOR CERVICAL SPINE FUSION. SPINE 2006; 31:542-7 AND SMUCKER JD, RHEE JM, SINGH D ET AL. INCREASED SWELLING COMPLICATIONS ASSOCIATED WITH OFF-LABEL USAGE OF RHBMP-2 IN THE ANTERIOR CERVICAL SPINE. SPINE 2006;31:2813-9. THERE ARE NO MDRS OR PUBLISHED LITERATURE TO SUPPORT THE OCCURRENCE OF THESE SYMPTOMS WHEN VITOSS IS USED WITHOUT BMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITOSS BONE GRAFT SUBSTITUTE MQV

    Patients

    Seq Age Sex Outcome Treatment
    1