BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALLOS INJECT BONE VOID FILLER 3CC

    MDR report key: 1966702 · Received December 29, 2010

    Report

    Report Number
    3003890476-2010-00002
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    July 30, 2010
    Report Date
    December 29, 2010
    Manufacturer
    SKELETAL KINETICS, LLC
    Product Code
    MQV
    PMA / PMN Number
    K051123
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER FIELD REPORT, THE PT DID EXPERIENCE A SERIOUS INJURY ASSOCIATED WITH ACUMED BONE GRAFT SYSTEM, CALLOS BONE VOID FILLER AND ACUMED ACUTRACK SCREW SYSTEM FOR ANKLE ARTHRODESIS. THE UNDERLYING RELATION OF THE INFECTION TO CALLOS INJECT IS DIFFICULT TO ISOLATE SINCE THE FIELD REPORT DENOTES THAT THE GRAFT SITE WAS LOCATED AT THE "PROXIMAL TIBIA", YET INFECTION WAS NOTED AT THE PROXIMAL TIBIA AND AT THE ANKLE SITES. ALSO, NOTED WAS THOSE ANKLE ARTHRODESIS CASES WHERE ANKLE WAS TREATED FOR SOME UNK UNDERLYING CAUSE WHERE THE SURGEON DECIDED TO ELIMINATE THE JOINT MOBILITY BY INSERTING SCREW INTO THE ANKLE JOINT.

    Description of Event or Problem · 1

    THE PHYSICIAN USED ACUMED'S BONE GRAFT SYSTEM TO HARVEST BONE FROM THE PATIENT'S PROXIMAL TIBIA AS PART OF ANKLE ARTHRODESIS CASE AND USED 3CC CALLOS INJECT TO BACKFILL THE HARVEST SITE. PT SUBSEQUENTLY DEVELOPED AN INFECTION AT BONE GRAFT SITE. INFECTION SPREAD UP TO KNEE AND DOWN TO ANKLE. PHYSICIAN SUSPECTED (BUT NOT SURE) THAT CALLOS MAY HAVE CAUSED THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALLOS INJECT BONE VOID FILLER 3CC CALCIUM SALT BONE VOID FILLER MQV SKELETAL KINETICS, LLC #10051003

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention ACUMED BONE GRAFT SYSTEM| ACUMED SCREW SYSTEM