BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACUMED CALLOS INJECT

    MDR report key: 1553728 · Received November 25, 2009

    Report

    Report Number
    3003890476-2009-00006
    Event Type
    Other
    Date Received
    November 25, 2009
    Report Date
    November 25, 2009
    Manufacturer
    SKELETAL KINETICS, LLC
    Product Code
    MQV
    PMA / PMN Number
    K051123
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBERS WERE AVAILABLE FOR THE INVESTIGATION, SO THE MFR HAD PERFORMED AN INVESTIGATION ON ALL POSSIBLE ACUMED CALLOS INJECT LOTS RELEASED BETWEEN 2008 AND 04/02/2009 (A TOTAL OF 24 LOTS). ALL LOTS MET FUNCTIONAL AND STERILIZATION CRITERIA RELEASE PER REVIEW OF THE BATCH RECORDS. ONGOING STABILITY TESTING OF THESE LOTS WERE TESTED EVERY THREE MONTHS AND THE TEST RESULTS INDICATED THAT ALL 24 LOTS WERE WITHIN SPECIFICATION (INJECTION, SETTING, TENSILE STRENGTH AND MIXING). THE RISK OF DEVELOPING SURGICAL SITE INFECTION FOLLOWING A SURGICAL PROCEDURE IS AFFECTED BY FACTORS SUCH AS THE GENERAL HEALTH OF THE PT, THE TYPE OF OPERATION AND THE PROCEDURE ITSELF. THE INFECTION RATE IN ORTHOPEDIC IMPLANT PRESENTED IN THREE SEPARATE STUDIES IS 7.8%, 5.76% AND 5% RESPECTIVELY. THERE IS NO REASON THAT ACUMED CALLOS INJECT CONTRIBUTES TO THE PH CHANGE; HOWEVER, IT IS VERY COMMON THAT PT'S PH WOULD CHANGE IF THERE IS AN INFECTION. NOTE: MDR OF THIS SAME INCIDENT SENT BY ACUMED, THE DISTRIBUTOR, ON 04/02/2009, MFR REPORT# 3025141-2009-00009.

    Description of Event or Problem · 1

    DURING THREE HIGH TIBIAL OSTEOTOMY (HTO) CASES, THE PHYSICIAN USED ACUMED CALLOS INJECT. ALL THREE PATIENT'S KNEES HAD TO BE WASHED OUT. THE KNEES BECAME INFECTED AND THEIR PH ARE HIGH. THE PHYSICIAN INDICATED THE CALLOS COULD BE AN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUMED CALLOS INJECT 21 CFR 888.3045 MQV MQV SKELETAL KINETICS, LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other