BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKELETAL DYNAMICS

    MDR report key: 11792531 · Received May 7, 2021

    Report

    Report Number
    3006742481-2021-00004
    Event Type
    Injury
    Date Received
    May 7, 2021
    Date of Event
    March 18, 2021
    Report Date
    May 6, 2021
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    HRS
    UDI-DI
    00841506105772
    PMA / PMN Number
    K171590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED TO MANUFACTURER FOR REVIEW/INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT THE PATIENT WAS NON-COMPLAINT WITH THE POST-OPERATIVE INSTRUCTIONS AND PROCEDURES WHICH LIKELY CONTRIBUTED TO THE EVENT. THE IFU STATES: "THE PATIENT SHOULD BE INFORMED ABOUT THE IMPORTANCE OF FOLLOWING THE POST-OPERATIVE REHABILITATION PRESCRIBED IN ORDER TO FULLY UNDERSTAND THE POSSIBLE LIMITATIONS IN ACTIVITIES OF DAILY LIVING. THE PATIENT MUST BE WARNED THAT FAILURE TO FOLLOW POSTOPERATIVE CARE INSTRUCTIONS MAY CAUSE THE IMPLANT OR TREATMENT TO FAIL." FAILURE TO FOLLOW POST-OPERATIVE CARE CAN CAUSE THE TREATMENT TO FAIL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FRACTURE DISPLACED POST-OPERATIVELY. IMPLANT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686257 SKELETAL DYNAMICS PROXIMAL ULNA PLATE HRS SKELETAL DYNAMICS Proximal Ulna Plate, 73mm, Right 00841506105772

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention