BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTEROLAT DIST TIB PLT, SS, RIGHT, 16H

    MDR report key: 7600185 · Received June 14, 2018

    Report

    Report Number
    1220246-2018-00216
    Event Type
    Injury
    Date Received
    June 14, 2018
    Date of Event
    May 8, 2018
    Report Date
    June 14, 2018
    Manufacturer
    ARTHREX INC.
    Product Code
    HRS
    UDI-DI
    00888867223288
    PMA / PMN Number
    K151732
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. 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 PATIENT UNDERWENT A SURGERY WHERE AN ARTHREX PLATE WAS IMPLANTED INTO THE PATIENT'S ANKLE. ON (B)(6) 2018, A REVISION SURGERY WAS PERFORMED TO REMOVE THE PLATE. FOLLOW-UP INVESTIGATION: THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2018. THE REP IS UNSURE HOW THE PLATE BROKE AND IF THE PATIENT WAS EXPERIENCING ANY PAIN OR DISCOMFORT PRIOR TO THE REVISION. THE SAME SURGEON PERFORMED BOTH, THE ORIGINAL SURGERY AND THE REVISION. NONE OF THE EXPLANTED HARDWARE IS AVAILABLE FOR RETURN. THE FOLLOWING DEVICES WERE ALSO EXPLANTED: AR-8827L-30 / LOT: 1530123, AR-8827L-32 / LOT: 10015375, AR-8827L-34 / LOT: 186497, AR-8835-20 / LOT: 10143062, AR-8835-22 / LOT: G52513, AR-8835-24 / LOT: 10050103, AR-8835-24 / LOT: W47426, AR-8835-26 / LOT: W47430.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444620 ANTEROLAT DIST TIB PLT, SS, RIGHT, 16H PLATE, FIXATION, BONE HRS ARTHREX INC. 5261603 00888867223288

    Patients

    Seq Age Sex Outcome Treatment
    1 Other