BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, CORTICAL

    MDR report key: 7005819 · Received November 7, 2017

    Report

    Report Number
    1220246-2017-00419
    Event Type
    Injury
    Date Received
    November 7, 2017
    Date of Event
    August 4, 2017
    Report Date
    November 7, 2017
    Manufacturer
    ARTHREX INC.
    Product Code
    HRS
    UDI-DI
    00888867011632
    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 FIVE SUBMISSIONS FROM THE SAME SINGLE EVENT. THE OTHERS ARE CC127085-LINE 210847-414, CC127085-LINE 210849-00417, CC127085-LINE 210851-00418 AND CC127085-LINE 210854-00420. 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 WENT WELL , GOOD ALIGNEMENT OF THE PLATE. ALL SCREWS WERE DRILLED WITH AR-13319. A CRACK WAS HEARD DURING THE FIXATION OF THE CORTICAL SCREWS. A FISSURE IS VISIBLE IN THE POST OP X-RAY. THE FOLLOWING DEVICES WERE IMPLANTED AT THE TIME OF PROCEDURE: AR-13110R-01 LOT 1142477 (CC127085 LINE 209692), AR-13280-70 LOT 10076262 (CC127085 LINE 210847), AR-13380-42 LOT 10081230 (CC127085 LINE 210849), AR-13380-46 LOT 10084866 (CC127085 LINE 210851), AR-13380-56 LOT 1142998 (CC127085 LINE 210852) AND AR-13380-50 LOT 10081367 (CC127085 LINE 210854).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786604 SCREW, CORTICAL PLATE, FIXATION, BONE HRS ARTHREX INC. 1142998 00888867011632

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AR-13110R-01 CONTURLK FEM OSTEO PLT RT LOT 1142477