BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALLOS INJECT DELIVERY KIT STERILE

    MDR report key: 1644188 · Received March 29, 2010

    Report

    Report Number
    3025141-2010-00010
    Event Type
    Injury
    Date Received
    March 29, 2010
    Date of Event
    February 23, 2010
    Report Date
    March 1, 2010
    Manufacturer
    SKELETAL KINETICS LLC
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY 15 MONTHS POST PLACEMENT OF CALLOS 3CC INJECT, THE CALLOS WAS OBSERVED TO BE FRAGMENTED AND HARD. THERE WAS A NON-UNION OF THE BONE AND THE TWO MOST DISTAL ULNAR SCREWS WERE BROKEN AT THE INTERFACE BETWEEN THE BONE AND THE ACUMED VDR PLATE. THE SURGEON HAD TO REMOVE ALL HARDWARE AND THE CALLOS. THE HARDWARE WAS REPLACED WITH A NEW PLATE AND AN ILIAC BONE GRAFT. THIS REPORT IS BEING SENT LATE BECAUSE OUR UNDERSTANDING WAS THAT THE REPORT MUST BE SUBMITTED WITHIN 30-DAYS OF RECEIPT. OUR PROCEDURES HAVE BEEN UPDATED TO REFLECT THE DISTRIBUTOR REPORTING REQUIREMENTS OF NO LATER THAN 10-DAYS. THE MANUFACTURER, SKELETAL KINETICS WAS INITIALLY NOTIFIED OF THIS EVENT VIA EMAIL ON (B)(6) 2010. OTHER MEDICAL DEVICE REPORTS RELATED TO THIS EVENT ARE LISTED BELOW: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALLOS INJECT DELIVERY KIT STERILE EXEMPT MQV SKELETAL KINETICS LLC 65-0099-S 08111004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention