BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, CORTICAL

    MDR report key: 7005820 · Received November 7, 2017

    Report

    Report Number
    1220246-2017-00425
    Event Type
    Injury
    Date Received
    November 7, 2017
    Date of Event
    September 29, 2017
    Report Date
    November 7, 2017
    Manufacturer
    ARTHREX INC.
    Product Code
    HRS
    UDI-DI
    00888867011618
    PMA / PMN Number
    K032187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THIS IS ONE OF SEVEN SUBMISSIONS FROM THE SAME SINGLE EVENT. THE OTHERS ARE CC127086-LINE 210844-412, CC127086-LINE 210845-00413, CC127086-LINE 210835-00421 AND CC127086-LINE 210838-00422, CC127086-LINE 210839-00423 AND CC127086-LINE 21084100888867011618-00424. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. AT THIS TIME, IT CANNOT BE DETERMINED HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DFO (DISTAL FEMORAL OSTEOTOMY) PROCEDURE AND SCREW DRILLING WENT WELL. GOOD ALIGNMENT OF THE PLATE. A CRACK WAS HEARD DURING THE FIXATION OF THE CORTICAL SCREWS. A FISSURE IN THE BONE WAS OBSERVED AT POST-OP RX. THE FOLLOWING DEVICES WERE IMPLANTED AT THE TIME OF PROCEDURE: AR-13110R-02 LOT 1478185 (CC127086 LINE 209696), AR-13280-35 LOT 1216262 (CC127086 LINE 210835), AR-13380-46 LOT 10129095 (CC127086 LINE 210838), AR-13280-45 LOT 10105613 (CC127086 LINE 210839), AR-13380-48 LOT 10073031 (CC127086 LINE 210841), AR-13380-52 LOT 10105330 (CC127086 LINE 210842), AR-13380-56 LOT 10123181 (CC127086 LINE 210844) AND AR-13280-70 LOT 10073626 (CC127086 LINE 210845).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786606 SCREW, CORTICAL PLATE, FIXATION, BONE HRS ARTHREX INC. 10105330 00888867011618

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AR-13110R-02 CONTURLK FEM OSTEO PLT RT LOT 1478185