BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUSCULOSKELETAL TRANSPLANT FOUNDATION PROVIDED 2 COBALT 60 IRRADIATED BONE GRAFT

    MDR report key: 2943774 · Received February 5, 2013

    Report

    Report Number
    MW5028821
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    September 14, 2011
    Report Date
    September 27, 2012
    Manufacturer
    MUSCULOSKELETAL TRANSPORT FOUNDATION
    Product Code
    NUN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, DR (B)(6) PLACED 2 COBALT 60 IRRADIATED DENTAL BONE GRAFTS IN MY 2 LOWER CANINE TEETH. THEY HAD TO BE REMOVED DUE TO NEUROLOGICAL SYMPTOMS THAT APPEARED AFTER THEIR PLACEMENT. THE NEUROLOGICAL SYMPTOMS DISAPPEARED AFTER THE IRRADIATED DENTAL BONE GRAFTS WERE TAKEN OUT ON (B)(6) 2011. THEN 2 MORE SURGERIES ON (B)(6) 2012 AND IN (B)(6)2012 WERE NECESSARY TO REMOVE EXOSTOSIS AND ACHIEVE HEALING. THE ORAL SURGEON WHO PERFORMED THE 3RD ORAL SURGERY IN (B)(6) 2012 DIAGNOSED ME WITH EXOSTOSIS. THIS IS NOT A GENETIC CONDITION AND THUS IT WAS PRODUCED IN THE IRRADIATED FIELD, WHERE COBALT 60 IRRADIATION FROM THE DENTAL BONE GRAFTS PASSED THROUGH. THE 2 COBALT IRRADIATED DENTAL BONE GRAFTS WERE SUPPLIED FROM MUSCULOSKELETAL TRANSPLANT FOUNDATION. THE 4 TEETH IN BETWEEN THE 2 LOWER CANINES WERE ALSO EXTRACTED, HOWEVER, THEY DID NOT RECEIVE COBALT 60 IRRADIATED BONE GRAFT MATERIAL. DIAGNOSIS OR REASON FOR USE: TO PLACE EXTRA BONE IN 2 LOWER CANINE TEETH AFTER EXTRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48396 MUSCULOSKELETAL TRANSPLANT FOUNDATION PROVIDED 2 COBALT 60 IRRADIATED BONE GRAFT COBALT 60 IRRADIATED BONE GRAFT MATERIA - STERILIZED WITH 1.8 M RADS OF COBALT 6 NUN MUSCULOSKELETAL TRANSPORT FOUNDATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R